FDA 510(k) clearance · back to tracker

GraftGun Universal Graft Delivery System (GDS®)

SurGenTec, LLC cleared K262581 on 2026-08-26, decision: substantially equivalent

K-number

K262581

Sponsor

SurGenTec, LLC

Device

GraftGun Universal Graft Delivery System (GDS®)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-26

Product code

FMF

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.5860

Official FDA record

Open K262581on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.