Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K991669Substantially Equivalent

Pms 750 Fingerswitch

CooperSurgical, Inc., Orange CT / Traditional, Substantially Equivalent

K991669 is the FDA 510(k) clearance record for PMS 750 FINGERSWITCH, a class II device, cleared for Wallach Surgical Devices, 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 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show no recalls naming K991669.

Clearance record

Decision date
Received
(90 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
Wallach Surgical Devices, Inc. 235 Edison Rd., Orange CT
510(k) summary
Summary
Third party review
No

Clearances, product code GEI

Trailing 12 months
45 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 20262
November 20260