Cytal Wound Matrix— 510(k) K152721
Substantially EquivalentAcell, Inc.
FDA 510(k) clearance K152721 for Cytal Wound Matrix, Substantially Equivalent on 2015-12-08. Applicant: Acell, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Acell, Inc.
- Product code
- Code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Columbia, MD, US
Recent devices under product code KGN
view allMore clearances from Acell, Inc.
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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 K152721
K-number listed on FDA's recall record- Z-1816-2026 — Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
- Z-1817-2026 — Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
- Z-1818-2026 — Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
- Z-1819-2026 — Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
- Z-1820-2026 — Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152721.
Data sourced from openFDA. This site is unofficial and independent of the FDA.