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
FOCClass II

Bag, Urine Collection, Newborn

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

FOC is the FDA product code for Bag, Urine Collection, Newborn, a class II device type, regulated under 21 CFR 876.5250. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FOC
Device name
Bag, Urine Collection, Newborn
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
4
Ingested recalls
0

Clearances, product code FOC

By decision year
4 clearances under product code FOC with a decision year between 1977 and 1995, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FOC by decision year
YearClearances
19771
19911
19941
19951

Applicants with the most clearances

Product code FOC
Applicants holding the most 510(k) clearances under product code FOC
ApplicantClearances
C.R. Bard Inc1
Cavitron Corp.1
Hollister, Inc.1
Rimeco Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code