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FDA 510(k)

Medline UNITE REFLEX Nitinol Staple System

K-Number: K210482 · 2021-04-22

ApplicantMedline Industries, Inc.
Decision Date2021-04-22
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE REFLEX Nitinol Staple System is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-04-22 under approval number K210482. 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 2021-04-22. It is manufactured by Medline Industries, Inc.. The 510(k) number is K210482.

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

Medline UNITE REFLEX Nitinol Staple System received FDA 510(k) clearance on 2021-04-22, under approval number K210482.

What company makes Medline UNITE REFLEX Nitinol Staple System?

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

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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