Cleared Special

K262581 - GraftGun Universal Graft Delivery System (GDS®)

K262581 is an FDA 510(k) clearance for GraftGun Universal Graft Delivery Syste..., manufactured by SurGenTec, LLC. The device is a Class 2 Orthopedic device with product code FMF cleared through the Special 510(k) pathway after a 30-day FDA review.

K262581 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
30d
Days
Class 2
Risk

K262581 is an FDA 510(k) clearance for the GraftGun Universal Graft Delivery System (GDS®). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on August 26, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 880.5860 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262581

510(k) Number K262581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2026
Decision Date August 26, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K262581.
SOL-M Luer Lock Syringe with Exchangeable Needle Tray
K252184 · Sol-Millennium Medical, Inc. · Aug 2026
Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
K253747 · Jiangsu Enjosim Medical Technology Co., Ltd. · Aug 2026
Ultra-Fine™ SAFETY Insulin Syringe
K260208 · embecta Medical II, LLC · Jul 2026
Sol-Glide Safety Needle
K253110 · Sol-Millennium Medical, Inc. · Jun 2026
Profoject™ Safety Needle
K260514 · CMT Health PTE., Ltd. · Jun 2026
Sofjec (Single use Needle)
K253112 · Hlb Lifescience Co., Ltd. · May 2026
K262581 · GraftGun Universal Graft Delivery System (GDS®)
Download PDF FDA Summary SurGenTec, LLC