510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934835Substantially Equivalent

Floval

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

K934835 is the FDA 510(k) clearance record for FLOVAL, a class II device, cleared for Olympus Corp. on under FDA product code FJL (Resectoscope). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K934835.

Clearance record

Decision date
Received
(256 days to decision)
Product code
FJL Resectoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Corp. 4 Nevada Dr., Lake Success NY
510(k) summary
Summary
Third party review
No

Clearances, product code FJL

Trailing 12 months

FDA records hold no clearances under product code FJL in the trailing twelve months.

FDA records show no clearances under product code FJL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FJL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260