Cleared Special

K011236 - MODIFICATION TO IMPLANTABLE CLIP (FDA 510(k) Clearance)

K011236 · Applied Medical Resources Corp. · General & Plastic Surgery device

May 2001

Decision

21d

Days

Class 2

Risk

K011236 is an FDA 510(k) clearance for the MODIFICATION TO IMPLANTABLE CLIP. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on May 14, 2001, 21 days after receiving the submission on April 23, 2001.

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

Submission Details

510(k) Number	K011236 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 23, 2001
Decision Date	May 14, 2001
Days to Decision	21 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF