INUMI™ Flex Needle
FDA 510(k) clearance K233884 · decided 2024-05-22
Clearance details
- K-number
- K233884
- Device name
- INUMI™ Flex Needle
- Applicant
- Galvanize Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-08
- Decision date
- 2024-05-22
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- OAB
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.