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

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KDH is the FDA product code for Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KDH
Device name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
23
Ingested recalls
2

Clearances, product code KDH

By decision year
23 clearances under product code KDH with a decision year between 1977 and 1999, 1992 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KDH by decision year
YearClearances
19772
19782
19821
19861
19891
19903
19913
19924
19941
19951
19972
19981
19991

Applicants with the most clearances

Product code KDH
Applicants holding the most 510(k) clearances under product code KDH
ApplicantClearances
Autovage4
Ethox Corp.2
Sherwood Medical Industries2
Tri-Med Specialties, Inc.2
Armm, Inc.1
Axiom Medical, Inc.1
B.Braun Medical, Inc.1
Ballard Medical Products1
Baxter Healthcare Corporation1
Biomedical Dynamics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code