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FDA 510(k)

KLS Martin Pure Pectus System

K-Number: K253660 · 2026-02-20

ApplicantKLS-Martin L.P.
Decision Date2026-02-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KLS Martin Pure Pectus System is a medical device manufactured by KLS-Martin L.P.. It received FDA 510(k) clearance on 2026-02-20 under approval number K253660. 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 KLS Martin Pure Pectus System?

KLS Martin Pure Pectus System is a medical device that received FDA 510(k) clearance on 2026-02-20. It is manufactured by KLS-Martin L.P.. The 510(k) number is K253660.

When was KLS Martin Pure Pectus System approved by the FDA?

KLS Martin Pure Pectus System received FDA 510(k) clearance on 2026-02-20, under approval number K253660.

What company makes KLS Martin Pure Pectus System?

KLS Martin Pure Pectus System is manufactured by KLS-Martin L.P..

What is the FDA product code for KLS Martin Pure Pectus System?

The FDA product code for KLS Martin Pure Pectus 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.

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