Clearance Summary
Peleton Universal Single Use Power System and Attachments received FDA 510(k) clearance under submission number K240071, sponsored by Peleton Surgical. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-04-04.
- Submission: K240071
- Applicant / Sponsor: Peleton Surgical
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 2024-04-04
Classification & Regulation
This clearance is catalogued under FDA product code SAM and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.