Cleared Special

K182838 - Geistlich Derma-Gide

K182838 · Geistlich Pharma AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
30d
Days
-
Risk

K182838 is an FDA 510(k) clearance for the Geistlich Derma-Gide. 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 8, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Geistlich Pharma AG devices

Submission Details

510(k) Number K182838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2018
Decision Date November 08, 2018
Days to Decision 30 days
Submission Type Special
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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

Regulatory Consultant

Biologics Consulting Group, Inc.
Samie Allen

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 84
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K182838.
Cytal Wound Matrix 3-Layer
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MariGen Wound Extra
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ProgenaMatrix
K182010 · Cell Constructs I, LLC · Jan 2019
NeoMatriX Wound Matrix
K181330 · Nextgen Biologics, Inc. · Oct 2018
SURECELL Gelling Fiber Wound Dressing
K173005 · Jiangsu Newvalue Medical Producst Co.,Ltd · May 2018
Cytal Wound Particulate
K180776 · Acell, Inc. · May 2018