CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle— 510(k) K171645

Name: FDA 510(k) clearance K171645
Creator: U.S. Food and Drug Administration
Published: 2017-07-25

Substantially Equivalent

Strukmyer Medical

FDA 510(k) clearance K171645 for CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle, Substantially Equivalent on 2017-07-25. Applicant: Strukmyer Medical. Device class: Unclassified.

Clearance details

Applicant: Strukmyer Medical
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2017-06-05
Decision date: 2017-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mesquite, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGN

view all

K260652 — ColActive Plus2026-09-09
K260711 — Accelagen Plus Surgical Matrix, 1cc (CG-01AP) +4 more2026-08-27
K260596 — Collagen Wound Powder2026-07-02
K260669 — Endoform Dermal Template2026-06-24
K253521 — ECMT-100 WMD2026-06-18

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K171645

K-number listed on FDA's recall record

Z-1789-2022 — DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300EClass III·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20220525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171645.

Data sourced from openFDA. This site is unofficial and independent of the FDA.