(144 days)
Not Found
No
The description focuses on the mechanical function of a surgical stapler and does not mention any AI/ML components or capabilities.
No
The device is a surgical stapler used for transecting and creating anastomoses, which are surgical procedures, not a therapeutic treatment itself.
No
The device is a surgical stapler used for transection and anastomoses of tissue. It is an operative device, not a diagnostic one.
No
The device description clearly states it is a "single patient use stapler" that delivers "316L stainless steel staples" and performs "transecting tissue". This indicates a physical, hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) outside of the body to provide information about a person's health.
- Device Function: The MicroCutter XCHANGE™30 is a surgical stapler used during surgical procedures to cut and staple tissue within the body. It is a surgical instrument, not a diagnostic tool that analyzes samples.
- Intended Use: The intended use clearly states its purpose is for "transection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix" during surgical procedures. This is a therapeutic/surgical function, not a diagnostic one.
The information provided describes a surgical device used for cutting and stapling tissue during surgery, which falls under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The MicroCutter XCHANGE™ 30 is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The staple (blue; 3.5mm) is compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small and large intestine, appendix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
Bench and animal testing were conducted.
Testing included:
- Integrity of the staple line via dimensional analysis of staples, visual inspection of staple line, and burst pressure testing.
- Dimensional tests for shaft diameter, jaw aperture, clamp gap, articulation angle, and staple line length.
- Ergonomics testing for cartridge load/unload force, force to articulate, force to deploy, force reset device, and torque to rotate device.
- Safety testing for deploy lockout safety mechanism.
- Functionality testing for clamp system, deployment system, and articulation.
- Reliability testing to ensure no degradation within indicated clinical deployments.
- Packaging Validation testing per ASTM D4169.
- Sterilization testing per ISO11137-2.
- Bioburden testing per ANSI/AAMI/ISO 11737-1:1995.
- Shelf life testing per ASTM F1980.
- Biocompatibility testing per ISO 10993-1, including Cytotoxicity, ISO Intracutaneous Reactivity, Hemolysis (in vitro), Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogen, and Coagulation, Thromboresistance.
Results demonstrated substantial equivalence to predicate devices and met design specifications.
Clinical Study Information:
Study type: Prospective, open label, multi-center study.
Sample size: 160 subjects enrolled, 423 deployments performed.
Data source: Subjects requiring surgical stapling of the stomach and/or intestine.
Key results:
- Primary endpoint: Statistical non-inferiority of composite related severe adverse event rate (composite of infection, leakage, bleeding, and strictures) compared to historical control from medical literature.
- One (1) composite severe adverse event related to the MicroCutter XCHANGE 30 System was reported in 153 patients (0.65%). The exact upper 95% confidence limit for this rate is 3.59%.
- The primary endpoint was met.
- 6 events reported for handsewn anastomoses and 6 events for other stapling devices in procedures where MicroCutter was used (not factored into primary endpoint calculation).
- Procedural success rate: 91.5% (140/153) when MicroCutter is used with other anastomoses modalities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance (MicroCutter European Trial I (METI)): Non-inferior to composite historical control.
Tissue Leak Pressure (Bench): No statistical difference p>0.05
Tissue Leak Pressure (Animal): No statistical difference p>0.05
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for "Cardica". The logo consists of a stylized, curved shape resembling an open bracket or a stylized letter "C" on the left side. To the right of this shape is the word "cardica" in a simple, sans-serif font, with a registered trademark symbol (®) next to it.
MicroCutter XCHANGE 30
JAN - 7 2014
510(k) Summary - Cardica MicroCutter XCHANGE™ 30
- A. Date Prepared January 2, 2014
B. Applicant Information
Cardica, Inc. 900 Saginaw Drive Redwood City, California 94063 Main: 650-364-9975 Fax: 650-364-3134
C. Contact Person
Vee Arya Senior QA/RA Manager
(650) 331-7152 direct (650) 644-7339 mobile (650) 331-7195 fax arya@cardica.com
Alternate Contact: Frederick Bauer Vice President of Operations
(650) 331-7163 direct (650) 331-7195 fax bauer@cardica.com
D. Establishment Registration Number 3004114958
E. Device Information
Common, Usual or Classification Name: Staple, Implantable Regulation Number: 21 CFR §878.4750 Product Code: GDW
- F. Trade Name MicroCutter XCHANGE™ 30
G. Legally Marketed Predicate Device(s)
Autosuture™ ENDO GIA™ Universal Stapler (K111825) Ethicon Proximate™ and Endopath™ Linear Staplers (K020779)
1
MicroCutter XCHANGE 30
cardıca
H. Device Description
The MicroCutter XCHANGE™ 30 is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The staple (blue; 3.5mm) is compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
I. Indications for Use
The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.
J. Comparison to Predicate Device
The Cardica MicroCutter XCHANGE™ 30 is substantially equivalent in its Indications for Use to the Covidien Autosuture™ ENDO™ GIA Stapler (K111825) and Ethicon Proximate™ Linear Staplers (K020779) in regards to the predicates' use for the transection, resection, and/or creation of anastomoses in surgical procedures involving gastrointestinal tissue.
The Cardica MicroCutter XCHANGE™ 30 is substantially equivalent in design and performance specifications to the Covidien Autosuture™ ENDO™ GIA Universal Stapler trigger handle, shaft and end-effecter function (K111825) and the Ethicon Proximate™ Linear Cutters' and Staplers' staple cartridge (K020779).
K. Technological Characteristics
The Cardica MicroCutter XCHANGE™ 30 is a cartridge based stapling device with a 5mm diameter shaft, capable of unlimited rotation and articulation up to 160° (80° degrees in each direction) in 20° increments. Predicate devices are also cartridge based, offer varying amounts of shaft rotation (90° to unlimited rotation) and less articulation range (80° - 90° total compared to 160°).
The MicroCutter XCHANGE™ 30 Blue Cartridge delivers a 30mm staple line consisting of two double-staggered rows (4 rows total) of D-shaped staples constructed of medical grade 316L stainless steel. The outermost rows contain 12 staples each, while the inner rows contain 13 staples each, for a total of 50 staples. Predicate devices can be used with various cartridges to deliver titanium staples ranging from 30 - 90mm, consisting of either two, double-staggered rows (4 rows total) or two, triple staggered rows (6 rows total).
One of the primary differentiating factors in the design of the MicroCutter XCHANGE™ 30 staple is that the staples are medical grade 316L stainless steel, which is a higher strength material than titanium alloy used in other stapling products. Current B-shaped staples are formed by buckling the tines. The forces required to accomplish the buckling typically represent the peak forces during staple formation. The MicroCutter XCHANGE™ 30 uses a guided, rotating form. The motion through the tissue is similar to that of a curved needle.
2
Image /page/2/Picture/1 description: The image shows the word "cardica" in a stylized font. The word is in black and has a registered trademark symbol after it. There is a curved line above and below the word, which gives the impression of a logo.
MicroCutter XCHANGE 30
The Cardica MicroCutter XCHANGE™ 30 has similar features as compared to the predicate devices as shown in table below:
| Feature | MicroCutter
XCHANGE 30 | ENDO GIA
Universal
(K111825) | PROXIMATE
Linear Cutters and
Staplers (K020779) |
|--------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Deployment Device | | | |
| Deployment | Cartridge based
deployment (up to 6
deployments per
tool) for single
patient use | Cartridge based
deployment (up
to 25
deployments per
tool) for single
patient use | Cartridge based
deployment (up to 4-
8 deployments per
tool) for single
patient use
(excepting Access
55) |
| Shaft Length | 340mm | 325mm | Not available |
| Transection Line
Length | 27mm | 30mm | Up to 100mm
(depending on
Cutter);
Staplers do not cut
(Staplers and Access
55) |
| End-Effector Opening | 5.3mm at tissue stop
(proximal);
16.7mm at distal
opening | 5.25mm at tissue
stop (proximal);
16.45mm at
distal opening | Adjustable parallel
jaws (excepting
Access 55) |
| Shaft Rotation | 360° | Same as subject
device | 90°; 30° shaft flex
(Access 55 only) |
| Articulation | 160° (80° each
direction) | 90° on the
roticulator model
(45° each
direction) | 80° (Access 55 only) |
| Staple | | | |
| Staple Material | Stainless steel
(316L) | Titanium | Titanium |
| Blue Unformed Staple
height | 3.22mm | 3.50mm | 3.50-3.85mm |
| Blue Formed Staple
Height | 0.75mm (compatible
with tissue thickness
that can be
compressed easily to
1.50mm) | 1.00mm
(compatible with
tissue thickness
that can be
compressed
easily to
1.50mm) | 1.00-1.50mm
(compatible with
tissue thickness that
can be compressed
easily to 1.00-
2.50mm) |
| Formed Staple
Configuration | D shaped | B shaped | B shaped |
| Staple Line | Two (2), double | Two (2), triple | Same as subject |
Page 3 – K132581 Cardica Response
3
Image /page/3/Picture/1 description: The image shows the text "510(k) Summary for K132581". The text is in a simple, sans-serif font and is left-aligned. The text is likely a title or heading for a document or section of a document related to a 510(k) summary for the product with the identifier K132581.
MicroCutter XCHANGE 30
.
.
| Feature | MicroCutter
XCHANGE 30 | ENDO GIA
Universal
(K111825) | PROXIMATE
Linear Cutters and
Staplers (K020779) |
|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------|
| Configuration | staggered rows | staggered rows | device |
| Staple Line Length | 30mm | 30mm, 45mm,
60mm | 10 (Cutters only),
30, 55 (Cutters and
Access 55), 60, 75
(Cutters only) and
90mm |
| Number of Staples Per
Deployment | 50 (One row of 13
and one row of 12
on either side of
transaction line) | 48 (for the 30mm
staple line length) | 58 and 74 (for the 30
and 55mm staple
line) |
| MRI Compatibility | MR-Conditional | MR-Safe | Same as subject
device |
| Biocompatibility | | | |
| Material
Biocompatibility
(Delivery Device and
Staple) | All components of
the Cardica
MicroCutter
XCHANGE 30 are
comprised of
materials that were
deemed acceptable
in accordance with
ISO Standard
10993-1. | Same as subject
device | Same as subject
device |
| Packaging, Sterilization and Shelf Life | | | |
| Packaging | PTFE tray with
Tyvek lid | Thermoformed
tray with Tyvek
lid | Thermoformed tray
with Tyvek lid |
| Sterilization
Sterility Assurance
Level | Gamma radiation
$10^{-6}$ | Ethylene Oxide
Not Available | Gamma radiation
Not Available |
| Shelf Life | 24 months | Not Available | Not Available |
| Performance | | | |
| Tissue Leak Pressure
(Bench) | No statistical difference p>0.05 | | Not Tested |
| Tissue Leak Pressure
(Animal) | No statistical difference p>0.05 | | Not Tested |
| Clinical Performance
(MicroCutter European
Trial I (METI): The
Cardica MicroCutter in
Surgical Stapling) | Non-inferior to
composite historical
control | Not Applicable | Not Applicable |
.
.
Image /page/3/Picture/5 description: The image shows the word "cardica" with a registered trademark symbol. The word is in a sans-serif font and is slightly italicized. To the left of the word is a stylized symbol that looks like a curved bracket or parenthesis.
4
Image /page/4/Picture/1 description: The image shows the word "carpica" in a stylized font. The word is accompanied by two curved lines, one above and one below the word, that converge to the left of the word. The font is sans-serif and appears to be bolded. There is a registered trademark symbol to the right of the word.
MicroCutter XCHANGE 30
L. Non-Clinical Performance Data
Bench and animal testing were conducted and the results demonstrated substantial equivalence to the predicate devices, and that the Cardica MicroCutter XCHANGE 30 met design specifications. A summary of the type of testing conducted is as follows:
- Integrity of the staple line was confirmed via dimensional analysis of the staples, � visual inspection of the staple line, and through burst pressure testing of the staple line.
- . Dimensional tests were conducted to confirm attributes for shaft diameter, jaw aperture, clamp gap, articulation angle, and staple line length.
- . Ergonomics testing was conducted to confirm device ergonomics and usability for cartridge load/unload force, force to articulate, force to deploy, force reset . device, and torque require to rotate device.
- Safety testing was completed to confirm the strength of the deploy lockout safety . mechanism to prevent advancement of the knife when a cartridge is not properly loaded into the device.
- . Functionality testing was completed to confirm device features for the clamp system, deployment system, and articulation.
- . Reliability testing was completed and demonstrated that device performance does not degrade when deploying within the indicated number of clinical deployments.
- . Packaging Validation testing was completed and passed in accordance with ASTM D4169.
- . Sterilization testing was completed and passed in accordance with ISO11137-2.
- Bioburden testing was conducted and passed in accordance with . ANSI/AAMI/ISO 11737-1:1995 Sterilization of Medical Devices-Microbiological Methods Part I: Estimation of Population of Microorganisms on Products.
- . Shelf life testing was completed and passed in accordance with ASTM F1980.
- 0 Biocompatibility testing was completed in accordance with ISO 10993-1 requirements. The following tests were completed and passed:
- Cytotoxicity 해
- ISO Intracutaneous Reactivity
- Hemolysis (in vitro)
- 트 Sensitization
- l Acute Systemic Toxicity
- I Material Mediated Pyrogen (as required)
- 트 Coagulation (as required)
- Thromboresistance (as required)
5
Image /page/5/Picture/1 description: The image shows the word "cardica" in a stylized font. The word is accompanied by a design element that resembles a stylized, elongated bracket or parenthesis on the left side. A horizontal line extends from the top of the bracket over the word and a similar line extends from the bottom of the bracket under the word.
MicroCutter XCHANGE 30
M. Clinical Study Information
The MicroCutter XCHANGE™ 30 System was evaluated in a prospective, open label, multi-center study with an All-Comers enrollment of subjects requiring surgical stapling of the stomach and/or intestine. 160 subjects were enrolled and followed postoperatively for at least 30 days. 423 deployments were performed. The primary endpoint was statistical non-inferiority of composite related severe adverse event rate (composite of infection, leakage, bleeding, and strictures) in study subjects when compared to composite severe adverse event rate (composite of infection, leakage, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature with regards to the comparable open and laparoscopic procedure. One (1) composite severe adverse event (composite of infection (non-dermal), leakage, bleeding, and strictures) related to the MicroCutter XCHANGE 10 30 System was reported in a total of one hundred fifty three (153) patients (0.65%). The exact upper 95% confidence limit for this rate is 3.59%. Based on these results, the primary endpoint was met.
Additionally, there were 6 events reported for handsewn anastomoses and 6 events for other stapling devices in procedures in which the MicroCutter was used. These events do not factor into the calculation of the primary endpoint event rate for the MicroCutter. There is a procedural success rate of 91.5% (140/153) when the MicroCutter is used with other anastomoses modalities.
| Stapler and Hand-sewn related
Severe Adverse Events
Categories | Hand-
sewn
related | Other
Stapler
related | MicroCutter
related | Total N |
|----------------------------------------------------------------------|--------------------------|-----------------------------|------------------------|---------|
| Leakages | 0 | 2 | 0 | 2 |
| Bleedings | 3 | 0 | 1 | 4 |
| Infections | 1 | 2 | 0 | 3 |
| Strictures | 0 | 1 | 0 | 1 |
| Other Complications | 2 | 1 | 0 | 3 |
| Total | 6 | 6 | 1 | 13 |
STAPLER AND HAND-SEWN ANASTOMOSIS RELATED PRIMARY ENDPOINT EVENTS
The following table depicts the tissue and number of deployments where the MicroCutter was used:
| MicroCutter Tissue Use | All Sites
N* (%) |
|--------------------------------------------|---------------------|
| Anastomose small intestine to
stomach | 1 (0.2) |
| Anastomosis of small intestine | 25 (5.9) |
| Anastomosis of small intestine to
colon | 13 (3.1) |
| Closure of enterotomy | 5 (1.2) |
| Transection of appendix | 57 (13.5) |
| Transection of colon | 81 (19.1) |
| Transection of common bile duct | 1 (0.2) |
Page 6 - K 132581 Cardica Response
6
Image /page/6/Picture/1 description: The image shows the logo for "cardica". The logo consists of a stylized, curved shape to the left of the word "cardica". The word "cardica" is in a simple, sans-serif font, and there is a registered trademark symbol to the upper right of the word.
MicroCutter XCHANGE 30
... . . . . . . . . . . . . . . . . . . . . . . . . .
| MicroCutter Tissue Use | All Sites
N* (%) |
|------------------------------------------|---------------------|
| Transection of duodenum | 19 (4.5) |
| Transection of
Mesocolon/Mesoappendix | 6 (1.4) |
| Transection of ovary | 1 (0.2) |
| Transection of small intestine | 213 (50.4) |
| Vascular transection | 1 (0.2) |
| Total | 423 |
*N = number of deployments
The following table depicts procedures by clinical approach:
| | Total
N* (%) |
|--------------------------|-----------------|
| Observation | 160 (N/A) |
| Open | 70 (43.8) |
| Laparoscopic | 75 (46.9) |
| Laparoscopic
assisted | 15 (9.4) |
| Converted | 0 (0) |
*N = number of observations
N. Conclusions
The MicroCutter XCHANGE™ 30 Stapler and Blue Cartridge have been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, clinical and non-clinical testing was conducted to validate the performance of the device and ensure the MicroCutter XCHANGE™ 30 Stapler and Blue Cartridge function as intended and meet design specifications. The comparison, clinical and non-clinical results demonstrate that the device is substantially equivalent to the predicate devices for its intended use.
Page 7 - K132581 Cardica Response
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7. 2014
Cardica Incorporated Ms. Vee Arya Senior Manager, Quality Assurance/Regulatory Affairs 900 Saginaw Drive Redwood City, California 94063
Re: K132581
Trade/Device Name: Cardica®MicroCutter XCHANGE™ 30 Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: November 21, 2013 Received: November 27, 2013
Dear Ms. Arya:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelors, manns of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I cottar statues and regairents, including, but not limited to: registration and listing (21
8
Page 2 - Ms. Vee Arya
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Binita S. Ashar -S. A 2014.01.07 16:32:32-05'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132581
Device Name Cardica@MicroCutter XCHANGETM 30
Indications for Use (Describe)
The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.
Type of Use (Select one or both, as applicable)
2017 26 223 2
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)