Cleared Special

K173385 - Graft Delivery

K173385 is an FDA 510(k) clearance for Graft Delivery, manufactured by Micromedics, Inc. (D/B/A Nordson Medical). The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 31-day FDA review.

K173385 · Micromedics, Inc. (D/B/A Nordson Medical) · General Hospital
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Nov 2017
Decision
31d
Days
Class 2
Risk

K173385 is an FDA 510(k) clearance for the Graft Delivery, DePuy Synthes. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Micromedics, Inc. (D/B/A Nordson Medical) (St. Paul, US). The FDA issued a Cleared decision on November 30, 2017 after a review of 31 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 Micromedics, Inc. (D/B/A Nordson Medical) devices

FDA 510(k) Submission Details - K173385

510(k) Number K173385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2017
Decision Date November 30, 2017
Days to Decision 31 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 129d · This submission: 31d
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 341
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K173385.
Graftgun Universal Graft Delivery System
K180937 · SurGenTec, LLC · May 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
Graftgun Universal Graft Delivery System
K170675 · SurGenTec, LLC · Jul 2017
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
K161606 · Terumo Europe N.V. · Feb 2017