510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K171916Substantially Equivalent

Single Use Hot Biopsy Forceps FD-231

Olympus Medical Systems Corp., Hachioji-Shi, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171916 is the FDA 510(k) clearance record for Single Use Hot Biopsy Forceps FD-231, a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code KGE (Forceps, Biopsy, Electric). FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show no recalls naming K171916.

Clearance record

Decision date
Received
(109 days to decision)
Product code
KGE Forceps, Biopsy, Electric
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, JP
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