Cleared Traditional

K850273 - ETHICON - CHOLANGIOCLIP (FDA 510(k) Clearance)

Apr 1985
Decision
84d
Days
Class 2
Risk

K850273 is an FDA 510(k) clearance for the ETHICON - CHOLANGIOCLIP. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on April 17, 1985, 84 days after receiving the submission on January 23, 1985.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K850273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1985
Decision Date April 17, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.4300