FFH — Collector, Urine, Pediatric, For Indwelling Catheter Class II

FDA Device Classification

FDA product code FFH covers "Collector, Urine, Pediatric, For Indwelling Catheter", a Class II medical device regulated under 21 CFR 876.5250. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FFH
Device Class
Class II
Regulation Number
876.5250
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K905016davolPEDIATRIC AND INFANT CATH KITSDecember 20, 1990
K896581laytech medicalPEDIATRIC DRAIN BAGJanuary 31, 1990
K871789mercury enterprisesINTECARE PEDIATRIC URINE COLLECTORAugust 10, 1987