510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K962653Substantially Equivalent

Microgyn Resection Loop, Coagulating Electrode, Ciss Sheath Electrode, Loop Electrode Kit and Coagulating Electrode Kit

Microgyn Corp., Taunton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962653 is the FDA 510(k) clearance record for MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT, a class II device, cleared for Microgyn Corp. on under FDA product code FAS (Electrode, Electrosurgical, Active, Urological). FDA records list one 510(k) clearance for Microgyn Corp. As of , FDA records show no recalls naming K962653.

Clearance record

Decision date
Received
(211 days to decision)
Product code
FAS Electrode, Electrosurgical, Active, Urological
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Microgyn Corp. 125 John Hancock Rd., Taunton MA
510(k) summary
Statement
Third party review
No

Clearances, product code FAS

Trailing 12 months
1 clearance under product code FAS in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FAS, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260