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FDA 510(k)

Endoform Reconstructive Template

K-Number: K153632 · 2016-06-16

ApplicantAroa Biosurgery Limited (Formerly Mesynthes Limited)
Decision Date2016-06-16
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endoform Reconstructive Template is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery Limited (Formerly Mesynthes Limited). It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K153632. 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 Endoform Reconstructive Template?

Endoform Reconstructive Template is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Aroa Biosurgery Limited (Formerly Mesynthes Limited). The 510(k) number is K153632.

When did Endoform Reconstructive Template receive FDA 510(k) clearance?

Endoform Reconstructive Template received FDA 510(k) clearance on 2016-06-16, under 510(k) number K153632.

Who is the listed applicant for Endoform Reconstructive Template?

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

What is the FDA product code for Endoform Reconstructive Template?

The FDA product code for Endoform Reconstructive Template is FTL.

Other records listing Aroa Biosurgery Limited (Formerly Mesynthes Limited) 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.

K153633Endoform Reconstructive Template

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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