510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950776Substantially Equivalent

Bipolar Snare

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950776 is the FDA 510(k) clearance record for BIPOLAR SNARE, a class I device, cleared for Cook Urological, Inc. on under FDA product code GAE (Snare, Surgical). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K950776.

Clearance record

Decision date
Received
(56 days to decision)
Product code
GAE Snare, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Summary
Third party review
No

Clearances, product code GAE

Trailing 12 months

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

FDA records show no clearances under product code GAE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAE, 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