FDA 510(k)

SurgiWrap FROST

K-Number: K200918 · 2021-01-07

Decision Date2021-01-07

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SurgiWrap FROST is the device name listed in this FDA 510(k) record. The listed applicant is Mast Biosurgery. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K200918. 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 SurgiWrap FROST?

SurgiWrap FROST is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Mast Biosurgery. The 510(k) number is K200918.

When did SurgiWrap FROST receive FDA 510(k) clearance?

SurgiWrap FROST received FDA 510(k) clearance on 2021-01-07, under 510(k) number K200918.

Who is the listed applicant for SurgiWrap FROST?

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

What is the FDA product code for SurgiWrap FROST?

The FDA product code for SurgiWrap FROST is FTL.

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 Production K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

Official Source

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