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

Bandage, Cast

21 CFR 890.3025 / Physical Medicine
FDA source (opens on fda.gov)

ITG is the FDA product code for Bandage, Cast, a class I device type, regulated under 21 CFR 890.3025. As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
ITG
Device name
Bandage, Cast
Regulation
21 CFR 890.3025
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
37
Ingested recalls
3

Clearances, product code ITG

By decision year
37 clearances under product code ITG with a decision year between 1976 and 1987, 1977 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code ITG by decision year
YearClearances
19763
19776
19794
19806
19815
19824
19835
19842
19861
19871

Applicants with the most clearances

Product code ITG
Applicants holding the most 510(k) clearances under product code ITG
ApplicantClearances
Hexcel Medical4
Johnson & Johnson Professionals, Inc.3
Secol Co.3
Solar Laboratories, Inc.3
Cutter Laboratories, Inc.2
Smith & Nephew, Inc.2
Stan-Pak Ent.2
Zimmer GmbH2
3M Company1
American Medical Disposable, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 228 companies shown, in name order