Cleared Traditional

K100927 - SURGIAID (FDA 510(k) Clearance)

K100927 · Maxigen Biotech, Inc. · General & Plastic Surgery device

Feb 2011

Decision

303d

Days

Risk

K100927 is an FDA 510(k) clearance for the SURGIAID. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Maxigen Biotech, Inc. (Flagstaff, US). The FDA issued a Cleared decision on February 2, 2011, 303 days after receiving the submission on April 5, 2010.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K100927 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 05, 2010
Decision Date	February 02, 2011
Days to Decision	303 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF