510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971838Substantially Equivalent

Micro Electrodes

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

K971838 is the FDA 510(k) clearance record for MICRO ELECTRODES, a class II device, cleared for CooperSurgical, Inc. on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 103 510(k) clearances for CooperSurgical, Inc., from to . As of , FDA records show no recalls naming K971838.

Clearance record

Decision date
Received
(170 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
CooperSurgical, Inc. 15 Forest Pkwy., Shelton CT
510(k) summary
Summary
Third party review
No

Clearances, product code KNF

Trailing 12 months
1 clearance under product code KNF in the twelve months to November 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260