# K091869: Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears

- Pathway: 510(k) (Special)
- Applicant: Covidien Lp, Formerly Registered AS United States
- Decided: Sep 1, 2009 after 70 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904578 (1990). 5 ancestors in all.
52 later devices descend from it; 5 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951589: Manual Surgical Insrument, United States Surgical, A Division of Tyco Healthc (1995) Summary page 1.
- K914753: Auto Suture (R) Articulating Endoscopic Clamp, United States Surgical, A Division of Tyco Healthc (1992) Summary page 1.
- K914752: Auto Suture (R) Articulating Endoscopic Scissors, United States Surgical, A Division of Tyco Healthc (1992) Summary page 1.
- K905426: Auto Suture Modified Endo Stream Suc./Irri. Device, United States Surgical, A Division of Tyco Healthc (1991) Summary page 1.
- K904578: Modification Auto Suture (R) Endoscopic Clamp, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.

## Most influential descendants
- K122532: DA Vinci Single-Site Instruments and Accessories (2013), 39 descendants of its own
- K131962: DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories (2014), 22 descendants of its own
- K173906: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (2018), 21 descendants of its own
- K182371: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (2019), 20 descendants of its own
- K202571: da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (2020), 14 descendants of its own

## Indications for use
The SILS TM Clincher* single use articulating clincher has application in a variety of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures. The SILSTM Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer. The SILS TM Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. The SILS TM L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery. The SILS TM Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

Source page: https://510kreport.com/device/K091869
Methodology: https://510kreport.com/methodology