510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K033368Substantially Equivalent

Fossa Ureteral Open Lumen Stent

Fossa Medical, Inc., Boston MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033368 is the FDA 510(k) clearance record for FOSSA URETERAL OPEN LUMEN STENT, a class II device, cleared for Fossa Medical, Inc. on under FDA product code EYB (Catheter, Ureteral, Gastro-Urology). FDA records list 3 510(k) clearances for Fossa Medical, Inc., from to . As of , FDA records show no recalls naming K033368.

Clearance record

Decision date
Received
(36 days to decision)
Product code
EYB Catheter, Ureteral, Gastro-Urology
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fossa Medical, Inc. 580 Harrison Ave., 4th Floor, Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EYB

Trailing 12 months

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

FDA records show no clearances under product code EYB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EYB, 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