Cleared Special

K110038 - TRUCLEAR MORCELLATOR SYSTEM

K110038 is the FDA 510(k) clearance for TRUCLEAR MORCELLATOR SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Special 510(k) pathway after a 83-day FDA review.

K110038 · Smith & Nephew, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
83d
Days
Class 2
Risk

K110038 is an FDA 510(k) clearance for the TRUCLEAR MORCELLATOR SYSTEM. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on March 30, 2011 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K110038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2011
Decision Date March 30, 2011
Days to Decision 83 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 160d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 108
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K110038.
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
K121868 · Hologic, Inc. · Jul 2012
MYOSURE CONTROL UNIT
K120593 · Hologic, Inc. · Mar 2012
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · Smith & Nephew, Inc. · Nov 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · Smith & Nephew, Inc. · Mar 2011
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
K092278 · Gyrus Acmi, Inc. · Sep 2009
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
K071127 · Vision-Sciences, Inc. · Nov 2007