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FDA 510(k)

PROSTIM Injectable Inductive Graft

K-Number: K190283 · 2019-03-14

ApplicantWrightmedicaltechnologyinc
Decision Date2019-03-14
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROSTIM Injectable Inductive Graft is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K190283. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTIM Injectable Inductive Graft?

PROSTIM Injectable Inductive Graft is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K190283.

When did PROSTIM Injectable Inductive Graft receive FDA 510(k) clearance?

PROSTIM Injectable Inductive Graft received FDA 510(k) clearance on 2019-03-14, under 510(k) number K190283.

Who is the listed applicant for PROSTIM Injectable Inductive Graft?

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

What is the FDA product code for PROSTIM Injectable Inductive Graft?

The FDA product code for PROSTIM Injectable Inductive Graft is MQV.

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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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