Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K915296Substantially Equivalent

Monopolar Electrode

Lifeguard Medical Products, Inc., River Forest IL / Traditional, Substantially Equivalent

K915296 is the FDA 510(k) clearance record for MONOPOLAR ELECTRODE, a class II device, cleared for Lifeguard Medical Products, 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 12 510(k) clearances for Lifeguard Medical Products, Inc., from to . As of , FDA records show no recalls naming K915296.

Clearance record

Decision date
Received
(293 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
Lifeguard Medical Products, Inc. 400 Lathrop Ave., River Forest IL
510(k) summary
Statement
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