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FDA 510(k)

AceConnex Pre-Sutured Fascia

K-Number: K213046 · 2023-06-27

ApplicantAllosource
Decision Date2023-06-27
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AceConnex Pre-Sutured Fascia is the device name listed in this FDA 510(k) record. The listed applicant is Allosource. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K213046. 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 AceConnex Pre-Sutured Fascia?

AceConnex Pre-Sutured Fascia is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Allosource. The 510(k) number is K213046.

When did AceConnex Pre-Sutured Fascia receive FDA 510(k) clearance?

AceConnex Pre-Sutured Fascia received FDA 510(k) clearance on 2023-06-27, under 510(k) number K213046.

Who is the listed applicant for AceConnex Pre-Sutured Fascia?

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

What is the FDA product code for AceConnex Pre-Sutured Fascia?

The FDA product code for AceConnex Pre-Sutured Fascia is GAT.

Other records listing Allosource 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.

K170957ReConnex Pre-Sutured Tendon

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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