KPH — Catheter, Rectal For Continent Ileostomy Class I

FDA Device Classification

FDA product code KPH covers "Catheter, Rectal For Continent Ileostomy", a Class I medical device regulated under 21 CFR 876.5030. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
KPH
Device Class
Class I
Regulation Number
876.5030
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K813494waters instrumentsWATERS ILEAL RESERVOIR CATHETERDecember 31, 1981