Cleared Traditional

K011026 - FORTADERM WOUND DRESSING (FDA 510(k) Clearance)

K011026 · Organogenesis, Inc. · General & Plastic Surgery device

Jun 2001

Decision

70d

Days

Risk

K011026 is an FDA 510(k) clearance for the FORTADERM WOUND DRESSING. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on June 13, 2001, 70 days after receiving the submission on April 4, 2001.

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

Submission Details

510(k) Number	K011026 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 04, 2001
Decision Date	June 13, 2001
Days to Decision	70 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF