510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880748Substantially Equivalent

Ball Tip Fulgurating Electrode, 3 French

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

K880748 is the FDA 510(k) clearance record for BALL TIP FULGURATING ELECTRODE, 3 FRENCH, a class II device, cleared for Cook Urological, Inc. on under FDA product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K880748.

Clearance record

Decision date
Received
(162 days to decision)
Product code
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
Third party review
No

Clearances, product code KNS

Trailing 12 months
4 clearances under product code KNS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KNS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260