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FDA 510(k)

Memodyn Staple

K-Number: K161587 · 2017-02-01

ApplicantAustin & Associates, Inc./Telos Medical Equipment
Decision Date2017-02-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Memodyn Staple is a medical device manufactured by Austin & Associates, Inc./Telos Medical Equipment. It received FDA 510(k) clearance on 2017-02-01 under approval number K161587. 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 Memodyn Staple?

Memodyn Staple is a medical device that received FDA 510(k) clearance on 2017-02-01. It is manufactured by Austin & Associates, Inc./Telos Medical Equipment. The 510(k) number is K161587.

When was Memodyn Staple approved by the FDA?

Memodyn Staple received FDA 510(k) clearance on 2017-02-01, under approval number K161587.

What company makes Memodyn Staple?

Memodyn Staple is manufactured by Austin & Associates, Inc./Telos Medical Equipment.

What is the FDA product code for Memodyn Staple?

The FDA product code for Memodyn 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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