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Macropore Surgical Barrier Film

by Macropore Biosurgery, Inc.

510(k) K023643

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023643 Date21 Feb 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MTZ
Device Class
Class II
Regulation
21 CFR Part 886.3320
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Macropore Surgical Barrier Film is a resorbable, malleable sheet made of polylactides (PLA) that acts as a protective wrap for orbital implants. It is used in enucleation surgery to provide soft tissue support and can be cut to the desired shape and size. When heated to approximately 55°C, the film becomes fully malleable, allowing for three-dimensional contouring to anatomical structures.

The device is supplied as a sterile, single-use implant wrap classified under FDA regulation number 886.3320 with product code MTZ and device class II. It received FDA 510(k) clearance (K023643) on February 21, 2003, as substantially equivalent to a predicate device. The film is intended for use in ophthalmic surgical settings and is not MRI conditional unless explicitly stated in the labeling.

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is the Macropore Surgical Barrier Film used for?

    The Macropore Surgical Barrier Film is a resorbable sheet made of polylactides (PLA) used in enucleation surgery to provide soft tissue support for orbital implants. It can be cut to size and heated to approximately 55°C for three-dimensional contouring to anatomical structures.

  • How is the Macropore Surgical Barrier Film supplied?

    The device is supplied as a sterile, single-use implant wrap. It is classified under FDA regulation number 886.3320 with product code MTZ and device class II, intended for use in ophthalmic surgical settings.

  • Is the Macropore Surgical Barrier Film reusable or MRI conditional?

    The Macropore Surgical Barrier Film is designed as a single-use implant and should not be reused. It is not MRI conditional unless explicitly stated in the product labeling.

  • What regulatory approval does the Macropore Surgical Barrier Film have?

    The Macropore Surgical Barrier Film received FDA 510(k) clearance (K023643) on February 21, 2003, as substantially equivalent to a predicate device. It is classified under FDA regulation number 886.3320 with product code MTZ and device class II.