Cleared Abbreviated

K062753 - FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC

K062753 is an FDA 510(k) clearance for FORSURE DISPOSABLE SYRINGE WITH NEEDLE, manufactured by Surgimed, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 147-day FDA review.

K062753 · Surgimed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
147d
Days
Class 2
Risk

K062753 is an FDA 510(k) clearance for the FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Surgimed, Inc. (Miami, US). The FDA issued a Cleared decision on February 8, 2007 after a review of 147 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Surgimed, Inc. devices

FDA 510(k) Submission Details - K062753

510(k) Number K062753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2006
Decision Date February 08, 2007
Days to Decision 147 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Standards-based clearance path.

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 407
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K062753.
GENIE, MODEL CH-200
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CAPTION APPLICATOR
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AUTO-FILL SYRINGE KIT, MODEL 7600
K063851 · Vascular Solutions, Inc. · Jan 2007
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
K063613 · Terumo Medical Corp. · Dec 2006
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · Medtronic Sofamor Danek USA, Inc. · Dec 2006