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FDA 510(k)

MACROPORE SURGIWRAP (TS)

K-Number: K012025 · 2001-12-03

ApplicantMacropore Biosurgery, Inc.
Decision Date2001-12-03
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MACROPORE SURGIWRAP (TS) 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 2001-12-03 under 510(k) number K012025. 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 SURGIWRAP (TS)?

MACROPORE SURGIWRAP (TS) is a medical device that received FDA 510(k) clearance on 2001-12-03. The listed applicant is Macropore Biosurgery, Inc.. The 510(k) number is K012025.

When did MACROPORE SURGIWRAP (TS) receive FDA 510(k) clearance?

MACROPORE SURGIWRAP (TS) received FDA 510(k) clearance on 2001-12-03, under 510(k) number K012025.

Who is the listed applicant for MACROPORE SURGIWRAP (TS)?

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 SURGIWRAP (TS)?

The FDA product code for MACROPORE SURGIWRAP (TS) is FTL.

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Other records listing Macropore Biosurgery, Inc. as applicant

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.

K042261MACROPORE PURICEL LIPOPLASTY SYSTEMK041105MACROPORE HYDROSORB SPINE SYSTEMK031955MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEETK031785MACROPORE CARDIO-WRAP (TS)K024169MACROPORE OS RECONSTRUCTIONK023643MACROPORE SURGICAL BARRIER FILM

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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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