510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963348Substantially Equivalent

Wallach Integration Unit

CooperSurgical, Inc., Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963348 is the FDA 510(k) clearance record for WALLACH INTEGRATION UNIT, a class II device, cleared for Wallach Surgical Devices, Inc. on under FDA product code HGI (Electrocautery, Gynecologic (And Accessories)). FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show 4 recalls naming K963348.

Clearance record

Decision date
Received
(205 days to decision)
Product code
HGI Electrocautery, Gynecologic (And Accessories)
Regulation
21 CFR 884.4120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Wallach Surgical Devices, Inc. 291 Pepe'S Farm Rd., Milford CT
510(k) summary
Statement
Third party review
No

Clearances, product code HGI

Trailing 12 months

FDA records hold no clearances under product code HGI in the trailing twelve months.

FDA records show no clearances under product code HGI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260