Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K932654Substantially Equivalent

Electrosurgial Instruments

MEDLINE INDUSTRIES, LP - Northfield, Mundelein IL / Traditional, Substantially Equivalent

K932654 is the FDA 510(k) clearance record for ELECTROSURGIAL INSTRUMENTS, a class II device, cleared for Medline Industries, Inc. 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 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K932654.

Clearance record

Decision date
Received
(265 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
Medline Industries, Inc. One Medline Pl., Mundelein IL
510(k) summary
Summary
Third party review
No

Clearances, product code GEI

Trailing 12 months
44 clearances under product code GEI in the twelve months to November 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20261
November 20260