ACELL UBM LYOPHILIZED WOUND DRESSING— 510(k) K021637

Name: FDA 510(k) clearance K021637
Creator: U.S. Food and Drug Administration
Published: 2002-12-19

Substantially Equivalent

Acell, Inc.

FDA 510(k) clearance K021637 for ACELL UBM LYOPHILIZED WOUND DRESSING, Substantially Equivalent on 2002-12-19. Applicant: Acell, Inc.. Device class: Unclassified.

Clearance details

Applicant: Acell, Inc.
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2002-05-17
Decision date: 2002-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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

More clearances from Acell, Inc.

view all

K241706 — MicroMatrix® UBM Particulate2024-07-11
K241724 — Cytal® Wound Matrix; Cytal® Burn Matrix2024-07-11
K230980 — MicroMatrix® Flex2023-09-22
K191734 — MatriStem UBM Pericardial Patch2019-11-22
K192725 — Cytal Wound Matrix 3-Layer2019-10-25

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 →

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