Peleton Universal Single Use Power System and Attachments
FDA 510(k) clearance K240071 · decided 2024-04-04
Clearance details
- K-number
- K240071
- Device name
- Peleton Universal Single Use Power System and Attachments
- Applicant
- Peleton Surgical
- Decision
- Substantially Equivalent
- Date received
- 2024-01-10
- Decision date
- 2024-04-04
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- SAM
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.