PELETON SURGICAL

FDA Device Registration & Listing · Scottsdale, AZ, US · Registration 3019932374

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019932374
FEI Number
3019932374
Entity Name
PELETON SURGICAL
City/State/Country
Scottsdale, AZ, US
Establishment Address
1435 North Hayden Road, Suite 100, Scottsdale, AZ 85257, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Peleton Surgical (Owner Number: 10082475)
Owner / Operator Contact Address
1435 North Hayden Road, Suite 100, Scottsdale, AZ 85257, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240071
PMA Number
N/A

All Registered Proprietary Names

Peleton Universal Single Use Power System and Attachments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2021-08-02
SAM Battery-Powered Instruments Charged Through Sterile Barriers General, Plastic Surgery Class 1 878.4820 2025-04-24

Official Correspondent

Andy Bala

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Peleton Surgical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K933337 R & D Batteries, Inc. R AND D BATTERY REPLACEMENT 1994-04-05
K873766 Bowen & Company, Inc. STERNAL POWER AWL 1988-11-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019932374. Last updated year: 2026. Please use registration number 3019932374 when referencing this establishment in official correspondence.
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