FDA 510(k)

JAWS Nitinol Staple System

K-Number: K223056 · 2023-02-16

Decision Date2023-02-16

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

JAWS Nitinol Staple System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2023-02-16 under approval number K223056. 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 JAWS Nitinol Staple System?

JAWS Nitinol Staple System is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Paragon 28, Inc.. The 510(k) number is K223056.

When was JAWS Nitinol Staple System approved by the FDA?

JAWS Nitinol Staple System received FDA 510(k) clearance on 2023-02-16, under approval number K223056.

What company makes JAWS Nitinol Staple System?

JAWS Nitinol Staple System is manufactured by Paragon 28, Inc..

What is the FDA product code for JAWS Nitinol Staple System?

The FDA product code for JAWS Nitinol Staple System is JDR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.