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FDA 510(k)

Polydioxanone Surgical Scaffold

K-Number: K181094 · 2018-08-02

ApplicantLntegra Lifesciences
Decision Date2018-08-02
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Polydioxanone Surgical Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Lntegra Lifesciences. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K181094. 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 Polydioxanone Surgical Scaffold?

Polydioxanone Surgical Scaffold is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Lntegra Lifesciences. The 510(k) number is K181094.

When did Polydioxanone Surgical Scaffold receive FDA 510(k) clearance?

Polydioxanone Surgical Scaffold received FDA 510(k) clearance on 2018-08-02, under 510(k) number K181094.

Who is the listed applicant for Polydioxanone Surgical Scaffold?

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

What is the FDA product code for Polydioxanone Surgical Scaffold?

The FDA product code for Polydioxanone Surgical Scaffold 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.

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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.

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