510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161186Substantially Equivalent

Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)

FUJIFILM Healthcare Americas Corporation, Wayne NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161186 is the FDA 510(k) clearance record for Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter), a class II device, cleared for Fujifilm Medical Systems U.S.A, Inc. on under FDA product code KGE (Forceps, Biopsy, Electric). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K161186.

Clearance record

Decision date
Received
(63 days to decision)
Product code
KGE Forceps, Biopsy, Electric
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fujifilm Medical Systems U.S.A, Inc. 10 High Pt. Dr., Wayne NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGE

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