Cleared Special

Graftgun Universal Graft Delivery System (K180937) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180937 · SurGenTec, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
30d
Days
Class 2
Risk

K180937 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 May 10, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device 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.

View all SurGenTec, LLC devices

Submission Details

510(k) Number K180937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2018
Decision Date May 10, 2018
Days to Decision 30 days
Submission Type Special
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
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Quality Solutions and Support
Stephen W. Inglese

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 244
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K180937.
Merit Syringe
K182216 · Merit Medical Systems, Inc. · Nov 2018
Merit Syringe
K182279 · Merit Medical Systems, Inc. · Nov 2018
BD Single Use, Hypodermic Syringe
K172670 · Becton, Dickinson and Company · Oct 2018
Nipro Syringe
K173029 · Nipro Medical Corporation · Mar 2018
Merit Syringe
K173601 · Merit Medical Systems, Inc. · Jan 2018
Merit Syringe
K171362 · Merit Medical Systems, Inc. · Aug 2017