(70 days)
The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .
The Re-New" Laparoscopic Scissors are surgical instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of surgical tips available, which include : disposable tips, and reusable tips. The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include: Metzenbaum, Mini, Hook, Endocut, and, Micro.
The provided text is a "510(k) Summary" for a medical device called "Re-New" Laparoscopic Instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device, "Quick Switch." The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies as requested in the prompt.
Therefore, I cannot extract the requested information from the provided text. The document is an FDA submission for market clearance, not a detailed technical study report.
{0}------------------------------------------------
10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
A. Submittor Information
Microline, Inc. 181 Elliott Street Beverly, MA 01915
(508) 922-9810 Telephone:
Contact Person: Mr. Huges de Laforcade President
Date Prepared: Mav 24, 1996
B. Device Identification
Common/Usual Name: Manual Detachable Surgical Instruments Proprietary Name: "Re-New" Laparoscopic Instruments
C. Identification of Predicate Device(s)
The "Re-New" Laparoscopic Instruments are substantially equivalent to their predicate, "Quick Switch" (K932648, previously cleared and currently marketed.
D. Device Description
The Re-New" Laparoscopic Scissors are surgical instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of surgical tips available, which include :
- · disposable tips, and
- . reusable tips.
The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include:
- · Metzenbaum,
- · Mini,
- · Hook,
- · Endocut, and,
- · Micro.
{1}------------------------------------------------
E. Substantial Equivalence
The technical characteristics of the "Re-New" Laparoscopic Instruments are almost identical to those of the Microline "Quick Switch". Refer to Table A for a comparison with their predicate. Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "Re-New" relative to its predicate.
The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .
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Image /page/2/Picture/0 description: The image shows a black and white graphic of a crescent shape. The crescent is thickest at the top and thins out towards the bottom. The shape is solid black, and the background is white.
ຂາຕອກມາງຂໍ້ມູນຂີ ອາໄດ້ຮັກວິຜົນ ໄຣນາຄຣM :ອໄດຣT ຖຸບຣາເຣຊຕາວວ A eldsT
| əldəsdə yലിന്തടയുടെ വിട്ടുണ്ട്. അതിനു പ്രാമ(นเว) นุเธนอา | 1ટદટદ | 24,424,2424'42 |
|---|---|---|
| Handle/Shaft: | ||
| SSBIOx-Number | 11A88888888 | il təsvirəsində kənd. Bu mənist |
| ləbələr Rəsmin fəsiləsinin cinsinə aid bitki növü. İstinadlar Rəssamlar Rəsmin Filmin fəsiləsinin cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə | "Otuick-Switch" | "well-ex-coller" |
| :າອານ ໄວ ຣາມ ນັກ ສະ ທ | Microline, Inc. | MICGOlline, Inc. |
: इवाग
puinteel 2 107 host puidsul Fi
səlburğu əldəsnəy
(பயர்) முறையங்கு
| sdil | sqi l | Disposable Assembly |
|---|---|---|
| Standard | prepuess | Electrocautery |
| stossipe | ടാറട്ടിവാ | selftC |
| 4.74 - 4.9 | ટે.દે | alasında bir sayının başırır. Bu başları bir bir bir bir bir bir bir bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da |
| - 0.0 | ટે.દે | aldesodsia |
| Tip Length Range (cm) |
sə y
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ടലപ്പാലാവപ ിലാശ്രമദ്ര (ാർമാടവേദമി 10 ക്കുട്ടുവാന്) വിശാടവയ്യച
(ว่างของรอาหตุก) to avisuloui) วidossobu วิ
sə)
sə)
9
ടന്നിലാ പ്രവിത
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.