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

Bag, Urine Collection, Leg, For External Use, Sterile

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

FAQ is the FDA product code for Bag, Urine Collection, Leg, For External Use, Sterile, a class I device type, regulated under 21 CFR 876.5250. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
FAQ
Device name
Bag, Urine Collection, Leg, For External Use, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
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
18
Ingested recalls
7

Clearances, product code FAQ

By decision year
18 clearances under product code FAQ with a decision year between 1978 and 1996, 1990 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FAQ by decision year
YearClearances
19783
19904
19922
19931
19942
19954
19962

Applicants with the most clearances

Product code FAQ
Applicants holding the most 510(k) clearances under product code FAQ
ApplicantClearances
MEDLINE INDUSTRIES, LP - Northfield3
Convatec, A Division of E.R. Squibb & Sons3
C.R. Bard Inc2
Baka Manufacturing Co., Inc.1
Custom Pack Reliability1
Cypress Medical Products LLC1
Fred Sammons, Inc.1
Inman Liebelt Corp.1
Nelmed Corp.1
Neotech Products, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 114 companies shown, in name order