Cytal Wound Matrix
FDA 510(k) clearance K152721 · decided 2015-12-08
Clearance details
- K-number
- K152721
- Device name
- Cytal Wound Matrix
- Applicant
- Acell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-21
- Decision date
- 2015-12-08
- Days to decision
- 78 days
- Clearance type
- Special
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. recall (Z-1816-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2026-04-15 |
| Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. recall (Z-1817-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2026-04-15 |
| Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. recall (Z-1818-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2026-04-15 |
| Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. recall (Z-1819-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2026-04-15 |
| Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. recall (Z-1820-2026) | Integra LifeSciences Corp. (NeuroSciences) | 2026-04-15 |