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Medeor Matrix, Models 30010-Xx (Hydrated); 30020-Xx (Dry)

by Kensey Nash Corp.

510(k) K091499

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091499 Date22 Oct 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTM
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MEDEOR MATRIX is a surgical mesh device. It is classified under product code FTM as Mesh, Surgical and is substantially equivalent to a predicate device under FDA 510(k) clearance K091499.

The device is supplied in two models: 30010-XX (hydrated) and 30020-XX (dry). It is intended for use in general and plastic surgery procedures and is regulated under 21 CFR 878.3300 as a Class II medical device with special controls.

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