510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K911702Substantially Equivalent

Olympus Retractable Valvulotome

Olympus Corp., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911702 is the FDA 510(k) clearance record for OLYMPUS RETRACTABLE VALVULOTOME, a class II device, cleared for Olympus Corp. on under FDA product code MGZ (Valvulotome). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K911702.

Clearance record

Decision date
Received
(255 days to decision)
Product code
MGZ Valvulotome
Regulation
21 CFR 870.4885
Device class
Class II
Review panel
Cardiovascular
Applicant
Olympus Corp. 4 Nevada Dr., Lake Success NY
Third party review
No

Clearances, product code MGZ

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