510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K965118Substantially Equivalent

Endocare Monopolar Electrode

Varian Medical Systems, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965118 is the FDA 510(k) clearance record for ENDOCARE MONOPOLAR ELECTRODE, a class II device, cleared for Endocare, Inc. on under FDA product code FAS (Electrode, Electrosurgical, Active, Urological). FDA records list 238 510(k) clearances for Varian Medical Systems, Inc., from to . As of , FDA records show no recalls naming K965118.

Clearance record

Decision date
Received
(67 days to decision)
Product code
FAS Electrode, Electrosurgical, Active, Urological
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endocare, Inc. 18 Technology Dr., Suite 134, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code FAS

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