(275 days)
To temporarily occlude an artery or vein with correct tension to produce minimal trauma to vessels. The different sizes and models are designed according to the type and size of the blood vessels, anatomical sites, and surgical techniques. Bulldog clamps are self-closing and are used for small vessels. The closing pressure of the GLOVER clamps can be adjusted using a nut and spring.
Applying forceps are used to apply bulldog clamps in deep surgical wounds.
To secure vascular occlusion of small vessels during surgery and to secure vascular occlusion during pediatric surgery.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for "Vascular Clamps." This type of document is an approval based on substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies is not present in this document.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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...".
Therefore, I cannot provide the requested information based on the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 8 1999
Ms. Daqmar S. Maeser C/O Geister Medizintechnik GMBH Business Support International Amstel 320-I 1017 AP Amsterdam The Netherlands
Re : K982365
Trade Name: Atraumatic Clamps, Bulldog Clamps, Micro Vascular Clamps and Applying Forceps Requlatory Class: II Product Code: DXC January 27, 1999 Dated: Received: January 29, 1999
Dear Ms. Maeser:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to
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Page 2 - Ms. Dagmar S. Maeser
your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4/8/99
Geister Medizintechnik GmbH
510(k) Number:
Device Name:
Vascular Clamp
Classification Name:
Vascular Clamp
Product Code:
scular Clamp
21 CFR 870.4450 74 DXC Class II
INDICATIONS FOR USE:
Atraumatic Clamps and Bulldog Clamps
Intended Use:
To temporarily occlude an artery or vein with correct tension to produce minimal trauma to vessels. The different sizes and models are designed according to the type and size of the blood vessels, anatomical sites, and surgical techniques. Bulldog clamps are self-closing and are used for small vessels. The closing pressure of the GLOVER clamps can be adjusted using a nut and spring.
- Various jaw types (straight, curved, or angled) Varieties:
Dimensional Ranges:
| Lengths: | 10.0 - 335 mm |
|---|---|
| Jaw Widths: | 0.8 - 10 mm |
| Jaw Lengths: | 5.0 - 200 mm |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Qitor M. H. for TTC
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 982365 510/k) Numb
1/3
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Geister Medizintechnik GmbH
510(k) Number:
Device Name:
Classification Name:
Vascular Clamp Vascular Clamp
Product Code:
21 CFR 870.4450 74 DXC Class II
INDICATIONS FOR USE (continued):
Applying Forceps
Intended Use:
Applying forceps are used to apply bulldog clamps in deep surgical wounds.
- Varieties: Various mouth pieces
- Length: 190 – 240 mm
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
II
Prescription Use _ (Per 21 CFR 801.109) OR V
Over-The-Counter Use
(Optional Format 1-2-96)
Chitoph. M. th for TJC
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices ﺳﻠ
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Geister Medizintechnik GmbH
510(k) Number:
| Device Name: | Vascular Clamp |
|---|---|
| Classification Name: | Vascular Clamp |
| Product Code: | 74 DXC Class II 21 CFR 870.4450 |
INDICATIONS FOR USE: (continued):
Micro Vascular Clamps
Intended Use
To secure vascular occlusion of small vessels during surgery and to secure vascular occlusion during pediatric surgery.
Varieties: Single clamps or double clamps
- With or without frame
- With or without approximator (movable)
- Different types for veins or arteries
- Two models (Acland and Acland mod.)
- For various vessel sizes
- Plain or black (Acland mod.)
Dimensional Ranges:
For Vessel Sizes: 0.3 - 5.0 mm Widths (without frames): 1.0 - 3.0 mm 7.0 - 36.0 mm Lengths:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
\checkmark
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Chitylm Al for TJC
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
982365
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).