510(k) · Cleared

Recalled · Class II · 2012

Disposable Bipolar Cord and Bipolar Forcep

K884656510(k) TraditionalCleared Nov 25, 198818-day reviewClass II21 CFR 878.4400Recalls 1

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

Dermacare · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 25, 1988 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled once.

Decided: Nov 25, 1988
Review: 18 days
Class: Class II
Product code: GEI
Recalls: 1
Predicates: 0

16 later devices descend from it, 2 citing it directly.

This deviceK884656 Disposable Bipolar Cord and Bipolar ForcepDermacare · 1988
Descendant · cites it directly · 13 of its ownK080187 Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008 · Recalled
Descendant · 2 generations on · 8 of its ownK110924 Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 2011 · Recalled
Descendant · 3 generations on · 7 of its ownK121426 Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012 · Recalled
Descendant · 2 generations on · 2 of its ownK182773 Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick…Faulhaber Pinzetten Ohg · 2019
Descendant · 4 generations on · 2 of its ownK162469 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps…Medos International SARL · 2016

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2008high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 16 · See all

K080187Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008 · cites it directly13descendants
K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 2011 · 2 generations on8descendants
K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 2012 · 3 generations on7descendants
K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating…Faulhaber Pinzetten Ohg · 2019 · 2 generations on2descendants
K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim…Medos International SARL · 2016 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K884656	Disposable Bipolar Cord and Bipolar Forcep	Dermacare	1988	—
+1	K080187	Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps	Olsen Medical	2008	1
+2	K110924	Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps	Synergetics, Inc.	2011	3
+3	K121426	Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps	Synergetics, Inc.	2012	19
+2	K182773	Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar…	Faulhaber Pinzetten Ohg	2019	—
+4	K162469	CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru…	Medos International SARL	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	2	0
2012	2	0
2013	1	0
2016	2	0
2019	1	0
2020	2	0
2022	2	0
2023	2	0
2024	1	0

FIG. 1 — Lineage of K884656, 1988–2024Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K080187	Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps	Olsen Medical	2008	13
K130669	Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps	Olsen Medical	2013	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 1, 2012	Class II	Z-1996-2012	Labeling mix-ups	Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K080187 (Olsen Medical, 2008) has gone furthest, with 13 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

https://510kreport.com/device/K884656 · printed Nov 3, 2026

Cite this page

510(k) Report. “K884656: Disposable Bipolar Cord and Bipolar Forcep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K884656

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Record history

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