Data / Medical devices / United States / Peleton Surgical
Peleton Surgical: FDA-registered device maker in Scottsdale, AZ, United States, 1 510(k) clearance
Peleton Surgical is registered with the FDA (registration 3019932374) in Scottsdale, AZ, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019932374
- Address
- 1435 North Hayden Road, Suite 100, Scottsdale, AZ, United States, 85257
- Owner or operator
- Peleton Surgical (10082475)
- Roles
- Specification developer
- First device listed
- August 2, 2021
- Registered through
- 2026
- Brand names listed
- Peleton Universal Single Use Power System and Attachments
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Battery-Powered Instruments Charged Through Sterile Barriers | SAM | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2024 | K240071 | Peleton Universal Single Use Power System and Attachments | SAM | Substantially Equivalent | Peleton Surgical | accessdata.fda.gov |
Compare with other makers
- All makers of Battery-Powered Instruments Charged Through Sterile Barriers
- All makers of Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Updated April 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.