Cleared Traditional

K170675 - Graftgun Universal Graft Delivery System

K170675 is an FDA 510(k) clearance for Graftgun Universal Graft Delivery System, manufactured by SurGenTec, LLC. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K170675 · SurGenTec, LLC · General Hospital
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Jul 2017
Decision
135d
Days
Class 2
Risk

K170675 is an FDA 510(k) clearance for the Graftgun Universal Graft Delivery System. 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 July 19, 2017 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all SurGenTec, LLC devices

FDA 510(k) Submission Details - K170675

510(k) Number K170675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2017
Decision Date July 19, 2017
Days to Decision 135 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 129d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K170675.
MHC Standard and NRFit Tip Syringes
K171131 · Mazza Healthcare, LLC · Nov 2017
Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
K171805 · Conceptomed AS · Sep 2017
Merit Syringe
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BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
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Freedom Syringe
K161812 · Procedure Products, Inc. · Mar 2017