ProgenaMatrix— 510(k) K182010

Name: FDA 510(k) clearance K182010
Creator: U.S. Food and Drug Administration
Published: 2019-01-17

Substantially Equivalent

Cell Constructs I, LLC

FDA 510(k) clearance K182010 for ProgenaMatrix, Substantially Equivalent on 2019-01-17. Applicant: Cell Constructs I, LLC. Device class: Unclassified.

Clearance details

Applicant: Cell Constructs I, LLC
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2018-07-27
Decision date: 2019-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GA, US

Download summary PDF View on FDA.gov ↗

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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 K182010

K-number listed on FDA's recall record

Z-1137-2022 — progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.Class II·Terminated·ProgenaCare·20220418

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182010.

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