Cleared Traditional

K123961 - SENTREX BIOSPONGE MPD (FDA 510(k) Clearance)

K123961 · Bionova Medical, Inc. · General & Plastic Surgery device

Apr 2013

Decision

100d

Days

Risk

K123961 is an FDA 510(k) clearance for the SENTREX BIOSPONGE MPD. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Bionova Medical, Inc. (Germantown, US). The FDA issued a Cleared decision on April 5, 2013, 100 days after receiving the submission on December 26, 2012.

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

Submission Details

510(k) Number	K123961 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 26, 2012
Decision Date	April 05, 2013
Days to Decision	100 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF