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FDA 510(k)

MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET

K-Number: K031955 · 2003-09-22

ApplicantMacropore Biosurgery, Inc.
Decision Date2003-09-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Macropore Biosurgery, Inc.. It received FDA 510(k) clearance on 2003-09-22 under 510(k) number K031955. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET?

MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET is a medical device that received FDA 510(k) clearance on 2003-09-22. The listed applicant is Macropore Biosurgery, Inc.. The 510(k) number is K031955.

When did MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET receive FDA 510(k) clearance?

MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET received FDA 510(k) clearance on 2003-09-22, under 510(k) number K031955.

Who is the listed applicant for MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET?

The FDA 510(k) record lists Macropore Biosurgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET?

The FDA product code for MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET is FTL.

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Other records listing Macropore Biosurgery, Inc. as applicant

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K042261MACROPORE PURICEL LIPOPLASTY SYSTEMK041105MACROPORE HYDROSORB SPINE SYSTEMK031785MACROPORE CARDIO-WRAP (TS)K024169MACROPORE OS RECONSTRUCTIONK023643MACROPORE SURGICAL BARRIER FILMK021164MACROPORE OS TRAUMA

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Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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