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

Protector, Ostomy

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

EXE is the FDA product code for Protector, 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 4 recalls.

Classification record

Product code
EXE
Device name
Protector, 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
4

Clearances, product code EXE

By decision year
3 clearances under product code EXE with a decision year between 1977 and 1991, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EXE by decision year
YearClearances
19772
19911

Applicants with the most clearances

Product code EXE
Applicants holding the most 510(k) clearances under product code EXE
ApplicantClearances
Convatec, A Division of E.R. Squibb & Sons1
Howmedica Corp.1
Rudolfo T. Sanchez1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 83 companies shown, in name order