FDA 510(k)

SurgiMend PRS Meshed, Revize-X

K-Number: K171357 · 2017-06-07

ApplicantIntegra Lifesciences Corporation (Owner of Tei Biosciences)

Decision Date2017-06-07

Product CodeOXH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SurgiMend PRS Meshed, Revize-X is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corporation (Owner of Tei Biosciences). It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K171357. The device is classified under product code OXH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiMend PRS Meshed, Revize-X?

SurgiMend PRS Meshed, Revize-X is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Integra Lifesciences Corporation (Owner of Tei Biosciences). The 510(k) number is K171357.

When did SurgiMend PRS Meshed, Revize-X receive FDA 510(k) clearance?

SurgiMend PRS Meshed, Revize-X received FDA 510(k) clearance on 2017-06-07, under 510(k) number K171357.

Who is the listed applicant for SurgiMend PRS Meshed, Revize-X?

The FDA 510(k) record lists Integra Lifesciences Corporation (Owner of Tei Biosciences) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurgiMend PRS Meshed, Revize-X?

The FDA product code for SurgiMend PRS Meshed, Revize-X is OXH.

Related Devices (Code: OXH)

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.

K251844Kerecis SurgiBind (50241)Kerecis Limited K202430Kerecis ReconstructKerecis Limited K160400Miromatrix Biological MeshMiromatrix Medical, Inc.

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.