# K993655: Micro-France Electrosurgical Instruments, Various

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Dec 21, 1999 after 53 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792365 (1979). 7 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980129: Instruments for Endoscopic Plastic Surgery (Eps), Richard Wolf Medical Instruments Corp. (1998) Summary page 1.
- K792365: Bipolar Forceps, Concept, Inc. (1979) Summary page 1.
- K890972: Hook Tip Surgical Cautery Electrode Blade, Instrument Makar, Inc. (1989) Summary page 1.
- K944992: Electrodes, Linvatec Corp. (1995) Summary page 1.
- K903302: Electrode, Electrosurgery, Megadyne Medical Products, Inc. (1990) Summary page 1.
- K895331: Electrosurgical Electrode, New England Surgical Instrument Corp. (1989) Summary page 1.
- K913514: Electrosurgical Unit Cable, Kirwan Surgical Products, Inc. (1991) Summary page 1.

## Most influential descendants
- K150959: Sutter Bipolar Forceps-Calvian (2015), 3 descendants of its own
- K172368: Bipolar Micro-Coagulation Forceps (2018), 2 descendants of its own
- K024304: Microsurgical Bipolar Handpiece (2003), 2 descendants of its own
- K080257: Microfrance Laparoscopic Manual Surgical Instruments (2008), 1 descendant of its own
- K040584: NMX-1000 (2004), 1 descendant of its own

## Recalls of this device
- Mar 7, 2016 · Class II · Z-1867-2016: 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: Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

## Indications for use
The electrosurgical instruments are intended to remove tissue and control bleeding.

Source page: https://510kreport.com/device/K993655
Methodology: https://510kreport.com/methodology