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
SUBSCRIBE / SIGN IN
FFHClass II

Collector, Urine, Pediatric, For Indwelling Catheter

21 CFR 876.5250 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FFH is the FDA product code for Collector, Urine, Pediatric, For Indwelling Catheter, a class II device type, regulated under 21 CFR 876.5250. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FFH
Device name
Collector, Urine, Pediatric, For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FFH

By decision year
3 clearances under product code FFH with a decision year between 1987 and 1990, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FFH by decision year
YearClearances
19871
19902

Applicants with the most clearances

Product code FFH
Applicants holding the most 510(k) clearances under product code FFH
ApplicantClearances
Davol, Inc.1
Laytech Medical Co.1
Mercury Enterprises, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order