Cleared Traditional

K110606 - MV INTRADERMIC NEEDLES

Also marketed or referenced as:
MAGIC NEEDLE MAGIC NEEDLE

K110606 is an FDA 510(k) clearance for MV INTRADERMIC NEEDLES, manufactured by M.V.S.R.L.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K110606 · M.V.S.R.L. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
210d
Days
Class 2
Risk

K110606 is an FDA 510(k) clearance for the MV INTRADERMIC NEEDLES. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by M.V.S.R.L. (Abano Terme, IT). The FDA issued a Cleared decision on September 29, 2011 after a review of 210 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K110606

510(k) Number K110606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date September 29, 2011
Days to Decision 210 days
Submission Type Traditional
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
81d slower than avg
Panel avg: 129d · This submission: 210d
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 633
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K110606.
CLICKFINE AUTOPROTECT PEN NEEDLE
K110312 · Ypsomed AG · Jan 2012
FINE JECT INSULIN PEN NEEDLE
K112332 · Twobiens Co., Ltd. · Jan 2012
EASY TOUCH
K112789 · Mhc Medical Products, LLC · Dec 2011
27 G X 1/2 K-PACK SURSHIELD NEEDLE
K111797 · Terumo Europe N.V. · Sep 2011
IMC BLOOD COLLECTION NEEDLE
K110656 · International Medsurg Connection · Aug 2011
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH
K111424 · Medpro Safety Products, Inc. · Jul 2011
K110606 · MV INTRADERMIC NEEDLES
Download PDF FDA Summary M.V.S.R.L.