510(k) · Cleared

Recalled · Class II · 2016

Micro-France Electrosurgical Instruments, Various

K993655510(k) TraditionalCleared Dec 21, 199953-day reviewClass II21 CFR 878.4400Recalls 2

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

Xomed, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 21, 1999 as substantially equivalent to K980129 (Richard Wolf Medical Instruments Corp., 1998) and 6 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1979. 10 later devices descend from it. It has been recalled 2 times.

Decided: Dec 21, 1999
Review: 53 days
Class: Class II
Product code: GEI
Recalls: 2
Predicates: 7

Its longest line of descent runs back 1 generation to K792365 (1979). 7 ancestors in all. 10 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK792365 Bipolar ForcepsConcept, Inc. · 1979
This deviceK993655 Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999
Descendant · cites it directly · 3 of its ownK150959 Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015
Descendant · 2 generations on · 2 of its ownK172368 Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018
Descendant · cites it directly · 2 of its ownK024304 Microsurgical Bipolar HandpieceNeomedix Corp. · 2003
Descendant · cites it directly · 1 of its ownK080257 Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008
Descendant · 2 generations on · 1 of its ownK040584 NMX-1000Neomedix Corp. · 2004

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003high 1 (2003) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all

K150959Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015 · cites it directly3descendants
K172368Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018 · 2 generations on2descendants
K024304Microsurgical Bipolar HandpieceNeomedix Corp. · 2003 · cites it directly2descendants
K080257Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008 · cites it directly1descendant
K040584NMX-1000Neomedix Corp. · 2004 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K792365	Bipolar Forceps	Concept, Inc.	1979	—
0 (this device)	K993655	Micro-France Electrosurgical Instruments, Various	Xomed, Inc.	1999	—
+1	K150959	Sutter Bipolar Forceps-Calvian	Sutter Medizintechnik GmbH	2015	—
+2	K172368	Bipolar Micro-Coagulation Forceps	Gunter Bissinger Medizintechnik GmbH	2018	—
+1	K024304	Microsurgical Bipolar Handpiece	Neomedix Corp.	2003	—
+1	K080257	Microfrance Laparoscopic Manual Surgical Instruments	Medtronic Xomed, Inc.	2008	—
+2	K040584	NMX-1000	Neomedix Corp.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0
1990	1	0
1991	1	0
1995	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2008	1	0
2010	1	0
2015	1	0
2018	1	0
2021	1	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K993655, 1979–2026Source: 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 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

Get a 510(k) Report

What was it cleared against? (7)

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
*	K980129	Instruments for Endoscopic Plastic Surgery (Eps) Summary page 1 …sue and control bleeding. Substantial Equivalence The Electrosurgical instruments are substantially equivalent to devices marketed by Richard Wolf Medical Instruments (K980129), Concept (K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical In…	Richard Wolf Medical Instruments Corp.	1998	—
*	K792365	Bipolar Forceps Summary page 1 …eding. Substantial Equivalence The Electrosurgical instruments are substantially equivalent to devices marketed by Richard Wolf Medical Instruments (K980129), Concept (K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical Instrument (K895331),…	Concept, Inc.	1979	—
*	K890972	Hook Tip Surgical Cautery Electrode Blade Summary page 1 …nce The Electrosurgical instruments are substantially equivalent to devices marketed by Richard Wolf Medical Instruments (K980129), Concept (K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical Instrument (K895331), and Kirwan Surgical Product…	Instrument Makar, Inc.	1989	—
*	K944992	Electrodes Summary page 1 …ical instruments are substantially equivalent to devices marketed by Richard Wolf Medical Instruments (K980129), Concept (K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical Instrument (K895331), and Kirwan Surgical Products (K913514). === Pa…	Linvatec Corp.	1995	—
*	K903302	Electrode, Electrosurgery Summary page 1 …uivalent to devices marketed by Richard Wolf Medical Instruments (K980129), Concept (K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical Instrument (K895331), and Kirwan Surgical Products (K913514). Public Health Service Food…	Megadyne Medical Products, Inc.	1990	—
*	K895331	Electrosurgical Electrode Summary page 1 …f Medical Instruments (K980129), Concept (K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical Instrument (K895331), and Kirwan Surgical Products (K913514). Public Health Service Food and Drug Administration 9200 Corporate Boul…	New England Surgical Instrument Corp.	1989	—
*	K913514	Electrosurgical Unit Cable Summary page 1 …(K792365), Instrument Maker (K890972), Linvatec (K944992), Megadyne Medical Products (K903302), New England Surgical Instrument (K895331), and Kirwan Surgical Products (K913514). Public Health Service Food and Drug Administration 9200 Corporate Boulevard DEC 2 1 1999 Rockville MD 20850 M…	Kirwan Surgical Products, Inc.	1991	—

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K150959	Sutter Bipolar Forceps-Calvian	Sutter Medizintechnik GmbH	2015	3
K024304	Microsurgical Bipolar Handpiece	Neomedix Corp.	2003	2
K080257	Microfrance Laparoscopic Manual Surgical Instruments	Medtronic Xomed, Inc.	2008	1
K210942	MicroFrance Monopolar and Bipolar Electrosurgical Instruments	Integra Microfrance	2021	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 7, 2016	Class II	Z-1867-2016	Other	Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Mar 7, 2016	Class II	Z-1866-2016	Other	Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 7 ancestors has a recall.
Of its descendants, K150959 (Sutter Medizintechnik GmbH, 2015) has gone furthest, with 3 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	—

What is it indicated for?

The electrosurgical instruments are intended to remove tissue and control bleeding.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993655 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993655: Micro-France Electrosurgical Instruments, Various.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993655

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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