INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301— 510(k) K072113

Clearance details

Applicant

Integra Lifesciences Corp.

Product code

Code KGN

Device class

Unclassified

Advisory panel

Unknown

Date received

2007-08-01

Decision date

2007-10-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plainsboro, NJ, US

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Other

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1338-2019 — Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.Class II·Terminated·Integra Limited·20190331

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072113.