510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955650Substantially Equivalent

Olympus Sd Series Snares

OLYMPUS Corporation of the Americas, Melville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955650 is the FDA 510(k) clearance record for OLYMPUS SD SERIES SNARES, a class II device, cleared for Olympus America, Inc. on under FDA product code FDI (Snare, Flexible). FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show 5 recalls naming K955650.

Clearance record

Decision date
Received
(108 days to decision)
Product code
FDI Snare, Flexible
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus America, Inc. Two Corporate Center Dr., Melville NY
510(k) summary
Summary
Third party review
No

Clearances, product code FDI

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