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 a medical device manufactured by Gm Dos Reis Industria E Comercio. It received FDA 510(k) clearance on 2025-12-19 under approval 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. It is manufactured by Gm Dos Reis Industria E Comercio. The 510(k) number is K251050.
When was Pectus Versa System approved by the FDA?
Pectus Versa System received FDA 510(k) clearance on 2025-12-19, under approval number K251050.
What company makes Pectus Versa System?
Pectus Versa System is manufactured by Gm Dos Reis Industria E Comercio.
What is the FDA product code for Pectus Versa System?
The FDA product code for Pectus Versa System is HRS.
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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.