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FDA 510(k)

Pectus Versa System

K-Number: K251050 · 2025-12-19

ApplicantGm Dos Reis Industria E Comercio
Decision Date2025-12-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pectus Versa System is the device name listed in this FDA 510(k) record. The listed applicant is Gm Dos Reis Industria E Comercio. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251050. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pectus Versa System?

Pectus Versa System is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Gm Dos Reis Industria E Comercio. The 510(k) number is K251050.

When did Pectus Versa System receive FDA 510(k) clearance?

Pectus Versa System received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251050.

Who is the listed applicant for Pectus Versa System?

The FDA 510(k) record lists Gm Dos Reis Industria E Comercio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pectus Versa System?

The FDA product code for Pectus Versa System is HRS.

Other records listing Gm Dos Reis Industria E Comercio as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250559GMReis Fibula Nail System

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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