510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904798Substantially Equivalent

Suprapubic Flow Controller

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

K904798 is the FDA 510(k) clearance record for SUPRAPUBIC FLOW CONTROLLER, a class II device, cleared for Olympus Corp. on under FDA product code KOB (Catheter, Suprapubic (And Accessories)). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K904798.

Clearance record

Decision date
Received
(394 days to decision)
Product code
KOB Catheter, Suprapubic (And Accessories)
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Corp. 4 Nevada Dr., Lake Success NY
Third party review
No

Clearances, product code KOB

Trailing 12 months

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

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