Cleared Special

K012219 - SCALPFIX CLIP SYSTEM
(FDA 510(k) Clearance)

K012219 · Aesculap, Inc. · General & Plastic Surgery device

Jul 2001

Decision

15d

Days

Class 2

Risk

K012219 is an FDA 510(k) clearance for the SCALPFIX CLIP SYSTEM. This device is classified as a Clip, Scalp (Class II - Special Controls, product code HBO).

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 31, 2001, 15 days after receiving the submission on July 16, 2001.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 882.4150.

Submission Details

510(k) Number	K012219 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 16, 2001
Decision Date	July 31, 2001
Days to Decision	15 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF