FDA 510(k)

AceConnex Pre-Sutured Fascia

K-Number: K213046 · 2023-06-27

Decision Date2023-06-27

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AceConnex Pre-Sutured Fascia is a medical device manufactured by Allosource. It received FDA 510(k) clearance on 2023-06-27 under approval 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. It is manufactured by Allosource. The 510(k) number is K213046.

When was AceConnex Pre-Sutured Fascia approved by the FDA?

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

What company makes AceConnex Pre-Sutured Fascia?

AceConnex Pre-Sutured Fascia is manufactured by Allosource.

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

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

Other Devices by Allosource

K170957ReConnex Pre-Sutured Tendon

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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.