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FDA 510(k)

PowerKnot High Strength Sutures

K-Number: K252225 · 2025-09-12

ApplicantMedacta International S.A.
Decision Date2025-09-12
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PowerKnot High Strength Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K252225. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerKnot High Strength Sutures?

PowerKnot High Strength Sutures is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Medacta International S.A.. The 510(k) number is K252225.

When did PowerKnot High Strength Sutures receive FDA 510(k) clearance?

PowerKnot High Strength Sutures received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252225.

Who is the listed applicant for PowerKnot High Strength Sutures?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerKnot High Strength Sutures?

The FDA product code for PowerKnot High Strength Sutures is GAT.

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Related Devices (Code: GAT)

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.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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