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FDA 510(k)

GraftGun Universal Graft Delivery System (GDS)

K-Number: K243580 · 2025-02-05

ApplicantSurGenTec, LLC
Decision Date2025-02-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GraftGun Universal Graft Delivery System (GDS) is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2025-02-05 under approval number K243580. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GraftGun Universal Graft Delivery System (GDS)?

GraftGun Universal Graft Delivery System (GDS) is a medical device that received FDA 510(k) clearance on 2025-02-05. It is manufactured by SurGenTec, LLC. The 510(k) number is K243580.

When was GraftGun Universal Graft Delivery System (GDS) approved by the FDA?

GraftGun Universal Graft Delivery System (GDS) received FDA 510(k) clearance on 2025-02-05, under approval number K243580.

What company makes GraftGun Universal Graft Delivery System (GDS)?

GraftGun Universal Graft Delivery System (GDS) is manufactured by SurGenTec, LLC.

What is the FDA product code for GraftGun Universal Graft Delivery System (GDS)?

The FDA product code for GraftGun Universal Graft Delivery System (GDS) is FMF.

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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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