MCH — Clip, Hemostatic Class II

FDA Device Classification

FDA product code MCH covers "Clip, Hemostatic", a Class II medical device regulated under 21 CFR 878.4300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MCH
Device Class
Class II
Regulation Number
878.4300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K040148boston scientificRESOLUTION HEMOSTASIS CLIPPING DEVICEApril 22, 2004
K972745eisner usaTITANIUM HEMOSTATIC CLIPOctober 21, 1997
K896998s.p.k. technologyATRAUCLIP (TANTALUM HEMOSTATIC CLIP)June 1, 1990