Cleared Special

K110038 - TRUCLEAR MORCELLATOR SYSTEM

K110038 is an FDA 510(k) clearance for TRUCLEAR MORCELLATOR SYSTEM, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Obstetrics & Gynecology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K110038

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
78d faster than avg
Panel avg: 161d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

HIH Device Classification - Class 2, Special Controls

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 174
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
MYOSURE ROD LENS SCOPE SEALS
K102686 · Interlace Medical, Inc. · Oct 2010
FEMEYE TWO
K093218 · Fem Suite, LLC · May 2010
K110038 · TRUCLEAR MORCELLATOR SYSTEM
Download PDF FDA Summary Smith & Nephew, Inc.