510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913721Substantially Equivalent

Fst Cath - Ui Usrodynamic Cath Introducer System

Fiberoptic Sensor Technlogies, Inc., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913721 is the FDA 510(k) clearance record for FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM, a class II device, cleared for Fiberoptic Sensor Technlogies, Inc. on under FDA product code FEN (Device, Cystometric, Hydraulic). FDA records list 11 510(k) clearances for Fiberoptic Sensor Technlogies, Inc., from to . As of , FDA records show no recalls naming K913721.

Clearance record

Decision date
Received
(49 days to decision)
Product code
FEN Device, Cystometric, Hydraulic
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fiberoptic Sensor Technlogies, Inc. 501 Avis Dr., Ann Arbor MI
510(k) summary
Statement
Third party review
No

Clearances, product code FEN

Trailing 12 months

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

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