510(k) · Cleared

Cleared

Cabot Medical Reusable Bipolar Cutting Forceps

K946109510(k) TraditionalCleared Nov 21, 1995342-day reviewClass II21 CFR 876.4300

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

Cabot Medical Corp. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Nov 21, 1995 after a 342-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 203 later devices descend from it.

Decided: Nov 21, 1995
Review: 342 days
Class: Class II
Product code: KNS
Recalls: None
Predicates: 0

203 later devices descend from it, 1 citing it directly.

This deviceK946109 Cabot Medical Reusable Bipolar Cutting ForcepsCabot Medical Corp. · 1995
Descendant · cites it directly · 202 of its ownK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
Descendant · 2 generations on · 128 of its ownK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
Descendant · 2 generations on · 114 of its ownK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
Descendant · 3 generations on · 102 of its ownK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
Descendant · 3 generations on · 65 of its ownK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled

Showing 5 of 203 descendants. See all descendants

Descendants cleared per year

1998high 18 (2018) · low 0 (1999)2026

Most influential descendants

Showing 5 of 203 · See all

K981916Ligasure Vessel Sealing SystemValleylab, Inc. · 1998 · cites it directly202descendants
K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005 · 2 generations on128descendants
K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · 2 generations on114descendants
K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007 · 3 generations on102descendants
K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · 3 generations on65descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K946109	Cabot Medical Reusable Bipolar Cutting Forceps	Cabot Medical Corp.	1995	—
+1	K981916	Ligasure Vessel Sealing System	Valleylab, Inc.	1998	—
+2	K051644	Valleylab Forcetriad Electrosurgical Generator	Valleylab	2005	—
+2	K031011	Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500	Valleylab, Inc.	2003	2
+3	K070162	Forcetriad Electrosurgical Generator; Ligasure Instruments	Valleylab,A Division of Tyco Healthcare Group LP	2007	—
+3	K092879	Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider	Valleylab	2009	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2003	3	0
2004	3	0
2005	3	0
2006	6	0
2007	5	0
2008	6	0
2009	2	0
2010	4	0
2011	9	0
2012	5	0
2013	8	0
2014	10	0
2015	14	0
2016	16	0
2017	13	0
2018	18	0
2019	6	0
2020	9	0
2021	12	0
2022	10	0
2023	12	0
2024	11	0
2025	7	0
2026	10	0

FIG. 1 — Lineage of K946109, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in KNS? 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 KNS device

#1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (203)

See all 203

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K981916	Ligasure Vessel Sealing System	Valleylab, Inc.	1998	202

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?

Of its descendants, K981916 (Valleylab, Inc., 1998) has gone furthest, with 202 descendants of its own.

How does its category compare?

All KNS devices

KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNS

11in 2025

2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNS

171in 2025

2007high 252 (2015) · low 30 (2016)2026

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

Recalls per year · KNS

14in 2024

2007high 41 (2021) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNS

1,504in 2025

2007high 1,533 (2024) · low 164 (2007)2025

MAUDE reports naming product code KNS, 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	1	—	3	164
2008	3	61	5	587
2009	3	212	2	1,027
2010	4	168	0	908
2011	1	—	2	860
2012	2	—	0	848
2013	2	—	0	449
2014	1	—	0	405
2015	3	252	0	406
2016	3	30	6	457
2017	3	48	1	446
2018	5	62	0	563
2019	7	66	0	668
2020	4	212	0	906
2021	4	139	41	814
2022	3	182	0	913
2023	9	83	0	976
2024	3	198	14	1,533
2025	11	171	0	1,504
2026	2	—	4	—

https://510kreport.com/device/K946109 · printed Nov 5, 2026

Cite this page

510(k) Report. “K946109: Cabot Medical Reusable Bipolar Cutting Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946109

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026