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FDA 510(k)

KLS Martin Pure Pectus System

K-Number: K250988 · 2025-12-11

ApplicantKLS-Martin L.P.
Decision Date2025-12-11
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 2025-12-11 under approval number K250988. 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 2025-12-11. It is manufactured by KLS-Martin L.P.. The 510(k) number is K250988.

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

KLS Martin Pure Pectus System received FDA 510(k) clearance on 2025-12-11, under approval number K250988.

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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