510(k) · Cleared

Cleared

Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears

K091869510(k) SpecialCleared Sep 1, 200970-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Covidien Lp, Formerly Registered AS United States · GCJ Laparoscope, General & Plastic Surgery

Cleared on Sep 1, 2009 as substantially equivalent to K951589 (United States Surgical, A Division of Tyco Healthc, 1995) and 4 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1990. 52 later devices descend from it.

Decided: Sep 1, 2009
Review: 70 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K904578 (1990). 5 ancestors in all. 52 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK904578 Modification Auto Suture (R) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc · 1990
This deviceK091869 Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009
Descendant · cites it directly · 39 of its ownK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled
Descendant · 2 generations on · 22 of its ownK131962 DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014
Descendant · 3 generations on · 21 of its ownK173906 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · Recalled
Descendant · 4 generations on · 20 of its ownK182371 da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · Recalled
Descendant · 5 generations on · 14 of its ownK202571 da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments…Intuitive Surgical, Inc. · 2020 · Recalled

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2012high 8 (2025) · low 1 (2012)2026

Most influential descendants

Showing 5 of 52 · See all

K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · cites it directly39descendants
K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2014 · 2 generations on22descendants
K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2018 · 3 generations on21descendants
K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2019 · 4 generations on20descendants
K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 2020 · 5 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904578	Modification Auto Suture (R) Endoscopic Clamp	United States Surgical, A Division of Tyco Healthc	1990	—
0 (this device)	K091869	Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears	Covidien Lp, Formerly Registered AS United States	2009	—
+1	K122532	DA Vinci Single-Site Instruments and Accessories	Intuitive Surgical, Inc.	2013	6
+2	K131962	DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories	Intuitive Surgical, Inc.	2014	—
+3	K173906	da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories	Intuitive Surgical, Inc.	2018	9
+4	K182371	da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories	Intuitive Surgical, Inc.	2019	4
+5	K202571	da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and…	Intuitive Surgical, Inc.	2020	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1992	2	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	2	0
2014	4	0
2015	1	0
2016	1	0
2017	2	0
2018	3	0
2019	2	0
2020	4	0
2021	6	0
2022	1	0
2023	7	0
2024	7	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K091869, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K951589	Manual Surgical Insrument Summary page 1 …Endoscopic Hand Instruments CLASSIFICATION NAME: Endoscopic Hand Instruments PREDICATE DEVICE(S): K951589: Auto SutureTM Modified Endoscopic Hand Instruments K914753: Auto SutureTM Articulating…	United States Surgical, A Division of Tyco Healthc	1995	—
*	K914753	Auto Suture (R) Articulating Endoscopic Clamp Summary page 1 …scopic Hand Instruments PREDICATE DEVICE(S): K951589: Auto SutureTM Modified Endoscopic Hand Instruments K914753: Auto SutureTM Articulating Endoscopic Clamp K914752: Auto SutureTM Articulating Endosc…	United States Surgical, A Division of Tyco Healthc	1992	—
*	K914752	Auto Suture (R) Articulating Endoscopic Scissors Summary page 1 …fied Endoscopic Hand Instruments K914753: Auto SutureTM Articulating Endoscopic Clamp K914752: Auto SutureTM Articulating Endoscopic Scissors K905426: Auto SutureTM Modified Endo St…	United States Surgical, A Division of Tyco Healthc	1992	—
*	K905426	Auto Suture Modified Endo Stream Suc./Irri. Device Summary page 1 …Articulating Endoscopic Clamp K914752: Auto SutureTM Articulating Endoscopic Scissors K905426: Auto SutureTM Modified Endo Stream Suction/Irrigation Device…	United States Surgical, A Division of Tyco Healthc	1991	—
*	K904578	Modification Auto Suture (R) Endoscopic Clamp Summary page 1 …K905426: Auto SutureTM Modified Endo Stream Suction/Irrigation Device K904578: Auto SutureTM Modified Endoscopic Clamp PRIOR RELATED SUBMISSION(S):…	United States Surgical, A Division of Tyco Healthc	1990	—

Also cleared against K951589: 4 other devices →

What descends from it? (52)

See all 52

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K122532	DA Vinci Single-Site Instruments and Accessories	Intuitive Surgical, Inc.	2013	39
K200501	ArtiSential Laparoscopic Instrument-Electrodes	Livsmed, Inc.	2020	4
K203603	Monopolar Hook	Human Xtensions, Ltd.	2021	3
K122299	Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical…	Transenterix, Inc.	2012	1
K140662	Flex Endoscopic Instruments	Design Standards Corp.	2014	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 5 ancestors has a recall.
Of its descendants, K122532 (Intuitive Surgical, Inc., 2013) has gone furthest, with 39 descendants of its own.
4 other devices also cite its predicate K951589.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

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…

Read the full statement (231 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091869 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091869: Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091869

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026