Pixie Skin Tag
FDA 510(k) clearance K240226 · decided 2024-10-18
Clearance details
- K-number
- K240226
- Device name
- Pixie Skin Tag
- Applicant
- Oystershell NV
- Decision
- Substantially Equivalent
- Date received
- 2024-01-26
- Decision date
- 2024-10-18
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- ORE
- Advisory committee
- General, Plastic Surgery
- Location
- Merelbeke, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.