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

Bag, Drainage, With Adhesive, Ostomy

21 CFR 876.5900 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FON is the FDA product code for Bag, Drainage, With Adhesive, Ostomy, a class I device type, regulated under 21 CFR 876.5900. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
FON
Device name
Bag, Drainage, With Adhesive, Ostomy
Regulation
21 CFR 876.5900
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
3
Ingested recalls
5

Clearances, product code FON

By decision year
3 clearances under product code FON with a decision year between 1977 and 1980, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FON by decision year
YearClearances
19771
19781
19801

Applicants with the most clearances

Product code FON
Applicants holding the most 510(k) clearances under product code FON
ApplicantClearances
Atlantic Surgical1
Hollister, Inc.1
Howmedica Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 88 companies shown, in name order