ellacor System with Micro-Coring Technology— 510(k) K252752
Substantially EquivalentCytrellis Biosystems, Inc.
FDA 510(k) clearance K252752 for ellacor System with Micro-Coring Technology, Substantially Equivalent on 2025-10-30. Applicant: Cytrellis Biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cytrellis Biosystems, Inc.
- Product code
- Code QAI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4430
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
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