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

Device, Paste-On For Incontinence, Sterile

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

EXI is the FDA product code for Device, Paste-On For Incontinence, Sterile, a class I device type, regulated under 21 CFR 876.5250. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EXI
Device name
Device, Paste-On For Incontinence, 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
7
Ingested recalls
0

Clearances, product code EXI

By decision year
7 clearances under product code EXI with a decision year between 1992 and 1997, 1997 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EXI by decision year
YearClearances
19922
19932
19973

Applicants with the most clearances

Product code EXI
Applicants holding the most 510(k) clearances under product code EXI
ApplicantClearances
Convatec, A Division of E.R. Squibb & Sons2
Hollister, Inc.2
Bioderm, Inc.1
MEDLINE INDUSTRIES, LP - Northfield1
Mediquest, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order