Darwin
by Luvo Medical Technologies Inc 2 variants
510(k) K212607
Darwin is a Class II device made by Luvo Medical Technologies Inc, cleared under FDA 510(k) K212607 on 15 Nov 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212607 | Date15 Nov 2021 | StatusActive |
Official records
- FDA 510(k) database K212607
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Luvo Medical Technologies, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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