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FDA 510(k)

Peleton Universal Single Use Power System and Attachments

K-Number: K240071 · 2024-04-04

ApplicantPeleton Surgical
Decision Date2024-04-04
Product CodeSAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Peleton Universal Single Use Power System and Attachments is the device name listed in this FDA 510(k) record. The listed applicant is Peleton Surgical. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K240071. The device is classified under product code SAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peleton Universal Single Use Power System and Attachments?

Peleton Universal Single Use Power System and Attachments is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Peleton Surgical. The 510(k) number is K240071.

When did Peleton Universal Single Use Power System and Attachments receive FDA 510(k) clearance?

Peleton Universal Single Use Power System and Attachments received FDA 510(k) clearance on 2024-04-04, under 510(k) number K240071.

Who is the listed applicant for Peleton Universal Single Use Power System and Attachments?

The FDA 510(k) record lists Peleton Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peleton Universal Single Use Power System and Attachments?

The FDA product code for Peleton Universal Single Use Power System and Attachments is SAM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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