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FDA 510(k)

Medline UNITE® REFLEX® Nitinol Staple System

K-Number: K231885 · 2023-08-09

ApplicantMedline Industries, LP
Decision Date2023-08-09
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® REFLEX® Nitinol Staple System is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2023-08-09 under approval number K231885. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline UNITE® REFLEX® Nitinol Staple System?

Medline UNITE® REFLEX® Nitinol Staple System is a medical device that received FDA 510(k) clearance on 2023-08-09. It is manufactured by Medline Industries, LP. The 510(k) number is K231885.

When was Medline UNITE® REFLEX® Nitinol Staple System approved by the FDA?

Medline UNITE® REFLEX® Nitinol Staple System received FDA 510(k) clearance on 2023-08-09, under approval number K231885.

What company makes Medline UNITE® REFLEX® Nitinol Staple System?

Medline UNITE® REFLEX® Nitinol Staple System is manufactured by Medline Industries, LP.

What is the FDA product code for Medline UNITE® REFLEX® Nitinol Staple System?

The FDA product code for Medline UNITE® REFLEX® Nitinol Staple System is JDR.

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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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