Cleared Traditional

K171842 - Geistlich Wound Matrix

K171842 · Geistlich Pharma AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
136d
Days
-
Risk

K171842 is an FDA 510(k) clearance for the Geistlich Wound Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on November 3, 2017 after a review of 136 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Geistlich Pharma AG devices

FDA 510(k) Submission Details - K171842

510(k) Number K171842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 115d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

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

Regulatory Consultant

Biologics Consulting Group, Inc.
Stephen P. Rhodes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 151
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K171842.
XCelliStem Wound Powder
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ologen Collagen Matrix
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gel-e Bandage
K172010 · Gel-E, Inc. (Formerly Remedium Technologies, Inc.) · Dec 2017
MicroMatrix
K172399 · Acell, Inc. · Oct 2017
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
K171645 · Strukmyer Medical · Jul 2017
Endoform Topical Matrix
K171231 · Aroa Biosurgery · Jun 2017