Cleared Traditional

TITANIUM LIGATING CLIPS

K896262 · Richard-Allan Medical Ind., Inc. · General & Plastic Surgery
Jan 1990
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K896262 is an FDA 510(k) clearance for the TITANIUM LIGATING CLIPS, a Applier, Hemostatic Clip (Class I — General Controls, product code HBT), submitted by Richard-Allan Medical Ind., Inc. (Richland, US). The FDA issued a Cleared decision on January 2, 1990, 64 days after receiving the submission on October 30, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K896262 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1989
Decision Date January 02, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HBT — Applier, Hemostatic Clip
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800