510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971416Substantially Equivalent

Olympus Oes Otv-S5c Video System

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

K971416 is the FDA 510(k) clearance record for OLYMPUS OES OTV-S5C VIDEO SYSTEM, a class II device, cleared for Olympus America, Inc. on under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology). FDA's definition for product code FET reads: "To allow for visualization of body cavities through an endoscope by projecting images to a monitor". FDA records list 150 510(k) clearances for OLYMPUS Corporation of the Americas, from to . As of , FDA records show no recalls naming K971416.

Clearance record

Decision date
Received
(91 days to decision)
Product code
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation
21 CFR 876.1500
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 FET

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