FDA 510(k)

MINNE TIES MMF Suture System

K-Number: K162046 · 2017-04-11

Decision Date2017-04-11

Product CodeDYX

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MINNE TIES MMF Suture System is the device name listed in this FDA 510(k) record. The listed applicant is Summit Medical, Inc.. It received FDA 510(k) clearance on 2017-04-11 under 510(k) number K162046. The device is classified under product code DYX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINNE TIES MMF Suture System?

MINNE TIES MMF Suture System is a medical device that received FDA 510(k) clearance on 2017-04-11. The listed applicant is Summit Medical, Inc.. The 510(k) number is K162046.

When did MINNE TIES MMF Suture System receive FDA 510(k) clearance?

MINNE TIES MMF Suture System received FDA 510(k) clearance on 2017-04-11, under 510(k) number K162046.

Who is the listed applicant for MINNE TIES MMF Suture System?

The FDA 510(k) record lists Summit Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINNE TIES MMF Suture System?

The FDA product code for MINNE TIES MMF Suture System is DYX.

Other records listing Summit Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.