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FDA 510(k)

MODIFICATION TO TRELEX MESH SURGICAL MESH

K-Number: K020110 · 2002-04-03

ApplicantBoston Scientific
Decision Date2002-04-03
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TRELEX MESH SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K020110. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO TRELEX MESH SURGICAL MESH?

MODIFICATION TO TRELEX MESH SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Boston Scientific. The 510(k) number is K020110.

When did MODIFICATION TO TRELEX MESH SURGICAL MESH receive FDA 510(k) clearance?

MODIFICATION TO TRELEX MESH SURGICAL MESH received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020110.

Who is the listed applicant for MODIFICATION TO TRELEX MESH SURGICAL MESH?

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

What is the FDA product code for MODIFICATION TO TRELEX MESH SURGICAL MESH?

The FDA product code for MODIFICATION TO TRELEX MESH SURGICAL MESH is OTN.

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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.

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