Cleared Traditional

K170900 - DASH 6 NRFit Lock Syringe + Accessories

K170900 is an FDA 510(k) clearance for DASH 6 NRFit Lock Syringe + Accessories, manufactured by Intervene Group, Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K170900 · Intervene Group, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
227d
Days
Class 2
Risk

K170900 is an FDA 510(k) clearance for the DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessor.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Intervene Group, Ltd. (Uxbridge, GB). The FDA issued a Cleared decision on November 9, 2017 after a review of 227 days - an extended review cycle.

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 Intervene Group, Ltd. devices

FDA 510(k) Submission Details - K170900

510(k) Number K170900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2017
Decision Date November 09, 2017
Days to Decision 227 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 129d · This submission: 227d
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 341
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K170900.
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