Cleared Special

K111797 - 27 G X 1/2 K-PACK SURSHIELD NEEDLE

K111797 is an FDA 510(k) clearance for 27 G X 1/2 K-PACK SURSHIELD NEEDLE, manufactured by Terumo Europe N.V.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 90-day FDA review.

K111797 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
90d
Days
Class 2
Risk

K111797 is an FDA 510(k) clearance for the 27 G X 1/2 K-PACK SURSHIELD NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on September 22, 2011 after a review of 90 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111797

510(k) Number K111797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2011
Decision Date September 22, 2011
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

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 694
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K111797.
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K111424 · Medpro Safety Products, Inc. · Jul 2011
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K110703 · Becton, Dickinson and Company · Jul 2011
K111797 · 27 G X 1/2 K-PACK SURSHIELD NEEDLE
Download PDF FDA Summary Terumo Europe N.V.