FDA 510(k)

Compressyn Staple

K-Number: K171473 · 2017-11-07

Decision Date2017-11-07

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Compressyn Staple is a medical device manufactured by Dallen Medical, Inc.. It received FDA 510(k) clearance on 2017-11-07 under approval number K171473. 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 Compressyn Staple?

Compressyn Staple is a medical device that received FDA 510(k) clearance on 2017-11-07. It is manufactured by Dallen Medical, Inc.. The 510(k) number is K171473.

When was Compressyn Staple approved by the FDA?

Compressyn Staple received FDA 510(k) clearance on 2017-11-07, under approval number K171473.

What company makes Compressyn Staple?

Compressyn Staple is manufactured by Dallen Medical, Inc..

What is the FDA product code for Compressyn Staple?

The FDA product code for Compressyn Staple is JDR.

Related Devices (Code: JDR)

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Official Source

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