510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K210942Substantially Equivalent

MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Integra Microfrance, Saint Aubin Le Monial Allier, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210942 is the FDA 510(k) clearance record for MicroFrance Monopolar and Bipolar Electrosurgical Instruments, a class II device, cleared for Integra Microfrance on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list one 510(k) clearance for Integra Microfrance. As of , FDA records show no recalls naming K210942.

Clearance record

Decision date
Received
(45 days to decision)
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Integra Microfrance Le Pavillon, Saint Aubin Le Monial Allier, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEI

Trailing 12 months
47 clearances under product code GEI in the twelve months to October 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
November 20254
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20260