510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093395Substantially Equivalent

Olympus Gf Type Uc180, Olympus Gf Type Uct180 Evis Exera II Ulatrasound Gastrovideoscope

Olympus Medical Systems Corp., Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093395 is the FDA 510(k) clearance record for OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show 4 recalls naming K093395.

Clearance record

Decision date
Received
(230 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Olympus Medical Systems Corporation 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYN

Trailing 12 months
52 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20260