Cleared Special

K152143 - TRUCLEAR Operative Hysteroscope 5C and Sheath 5C

K152143 is an FDA 510(k) clearance for TRUCLEAR Operative Hysteroscope 5C and ..., 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 30-day FDA review.

K152143 · Smith & Nephew, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
30d
Days
Class 2
Risk

K152143 is an FDA 510(k) clearance for the TRUCLEAR Operative Hysteroscope 5C and Sheath 5C. 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 September 2, 2015 after a review of 30 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 - K152143

510(k) Number K152143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2015
Decision Date September 02, 2015
Days to Decision 30 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
131d faster than avg
Panel avg: 161d · This submission: 30d
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 K152143.
MAKO 7
K160510 · Nvision Medical Corporation · Jun 2016
MAKO Device
K151275 · Nvision Medical · Nov 2015
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · Hologic, Inc. · Nov 2015
Schoelly Cystoscopes/Hysteroscopes and Accessories
K150158 · Schoelly Fiberoptic GmbH · Mar 2015
AED HYSTEROSCOPE AND ACCESSORIES
K141515 · National Advanced Endoscopy Devices, Inc. · Jan 2015
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K142029 · Hologic, Inc. · Nov 2014
K152143 · TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
Download PDF FDA Summary Smith & Nephew, Inc.