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FDA 510(k)

Liora Monofilament Scaffold

K-Number: K260474 · 2026-09-28

ApplicantTELA Bio, Inc.
Decision Date2026-09-28
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Liora Monofilament Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is TELA Bio, Inc.. It received FDA 510(k) clearance on 2026-09-28 under 510(k) number K260474. 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 Liora Monofilament Scaffold?

Liora Monofilament Scaffold is a medical device that received FDA 510(k) clearance on 2026-09-28. The listed applicant is TELA Bio, Inc.. The 510(k) number is K260474.

When did Liora Monofilament Scaffold receive FDA 510(k) clearance?

Liora Monofilament Scaffold received FDA 510(k) clearance on 2026-09-28, under 510(k) number K260474.

Who is the listed applicant for Liora Monofilament Scaffold?

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

What is the FDA product code for Liora Monofilament Scaffold?

The FDA product code for Liora Monofilament Scaffold is FTL.

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Other records listing TELA Bio, Inc. as applicant

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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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