Cleared Traditional

K072059 - GRIPPER MICRO NEEDLE

K072059 is an FDA 510(k) clearance for GRIPPER MICRO NEEDLE, manufactured by Smiths Medical MD, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K072059 · Smiths Medical MD, Inc. · General Hospital
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Nov 2007
Decision
98d
Days
Class 2
Risk

K072059 is an FDA 510(k) clearance for the GRIPPER MICRO NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 1, 2007 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Smiths Medical MD, Inc. devices

FDA 510(k) Submission Details - K072059

510(k) Number K072059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2007
Decision Date November 01, 2007
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 275
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K072059.
K-PACK II NEEDLE - 29G THIN WALL
K082820 · Terumo Europe N.V. · Oct 2008
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
K073188 · Smiths Medical Asd, Inc. · Feb 2008
STERICAN HYPODERMIC NEEDLES
K072247 · B.Braun Medical, Inc. · Nov 2007
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K071998 · Arrow Intl., Inc. · Sep 2007
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
K071785 · Smiths Medical Asd, Inc. · Aug 2007
BD HYPOINT NEEDLE
K070440 · Becton, Dickinson & CO · Mar 2007