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

Bag, Bile Collecting

21 CFR 876.5010 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EXF is the FDA product code for Bag, Bile Collecting, a class II device type, regulated under 21 CFR 876.5010. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
EXF
Device name
Bag, Bile Collecting
Regulation
21 CFR 876.5010
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
9
Ingested recalls
3

Clearances, product code EXF

By decision year
9 clearances under product code EXF with a decision year between 1990 and 2000, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EXF by decision year
YearClearances
19902
19911
19941
19961
19971
19981
19991
20001

Applicants with the most clearances

Product code EXF
Applicants holding the most 510(k) clearances under product code EXF
ApplicantClearances
Argon Medical Devices, Inc2
Uresil, LLC2
Medical Device Technologies, Inc.1
Medical Technologies of Georgia1
Merit Medical Systems, Inc.1
Navarre Biomedical, Ltd.1
Remington Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order