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FDA 510(k)

Clench Compression Staple

K-Number: K173775 · 2018-04-06

ApplicantF & A Foundation, LLC D.B.A. Reign Medical
Decision Date2018-04-06
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Clench Compression Staple is a medical device manufactured by F & A Foundation, LLC D.B.A. Reign Medical. It received FDA 510(k) clearance on 2018-04-06 under approval number K173775. 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 Clench Compression Staple?

Clench Compression Staple is a medical device that received FDA 510(k) clearance on 2018-04-06. It is manufactured by F & A Foundation, LLC D.B.A. Reign Medical. The 510(k) number is K173775.

When was Clench Compression Staple approved by the FDA?

Clench Compression Staple received FDA 510(k) clearance on 2018-04-06, under approval number K173775.

What company makes Clench Compression Staple?

Clench Compression Staple is manufactured by F & A Foundation, LLC D.B.A. Reign Medical.

What is the FDA product code for Clench Compression Staple?

The FDA product code for Clench Compression Staple 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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