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FDA 510(k)

VersaWrap

K-Number: K203600 · 2021-03-09

ApplicantAlafair Biosciences, Inc.
Decision Date2021-03-09
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VersaWrap is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2021-03-09 under 510(k) number K203600. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VersaWrap?

VersaWrap is a medical device that received FDA 510(k) clearance on 2021-03-09. The listed applicant is Alafair Biosciences, Inc.. The 510(k) number is K203600.

When did VersaWrap receive FDA 510(k) clearance?

VersaWrap received FDA 510(k) clearance on 2021-03-09, under 510(k) number K203600.

Who is the listed applicant for VersaWrap?

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

What is the FDA product code for VersaWrap?

The FDA product code for VersaWrap is FTM.

Other records listing Alafair Biosciences, 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.

K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)K240817VersaWrapK232029VersaWrap Nerve ProtectorK213163VersaWrap

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Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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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