Cleared Traditional

Geistlich Wound Matrix

K171842 · Geistlich Pharma AG · General & Plastic Surgery
Nov 2017
Decision
136d
Days
Risk

About This 510(k) Submission

K171842 is an FDA 510(k) clearance for the Geistlich Wound Matrix, a Wound Dressing With Animal-derived Material(s), submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on November 3, 2017, 136 days after receiving the submission on June 20, 2017. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K171842 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2017
Decision Date November 03, 2017
Days to Decision 136 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGN — Wound Dressing With Animal-derived Material(s)
Device Class

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