Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Endoform Reconstructive Template - Non Absorbable

K-Number: K181935 · 2018-12-04

ApplicantAroa Biosurgery , Ltd.
Decision Date2018-12-04
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Endoform Reconstructive Template - Non Absorbable is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K181935. 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 - Non Absorbable?

Endoform Reconstructive Template - Non Absorbable is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K181935.

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

Endoform Reconstructive Template - Non Absorbable received FDA 510(k) clearance on 2018-12-04, under 510(k) number K181935.

Who is the listed applicant for Endoform Reconstructive Template - Non Absorbable?

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

What is the FDA product code for Endoform Reconstructive Template - Non Absorbable?

The FDA product code for Endoform Reconstructive Template - Non Absorbable is FTL.

Related Clinical Trials

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.

NCT05243966Myriad™ Augmented Soft Tissue Reconstruction RegistryRECRUITING

Other records listing Aroa Biosurgery , Ltd. 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.

K260669Endoform Dermal TemplateK250598Endoform Reconstructive Template - PLGAK231305Endoform Dental MembraneK223373Enivo™K200502Myriad ParticlesK200413Symphony

View all 10 devices →

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.

↑