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
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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.

View all Smith & Nephew, Inc. devices

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
130d faster than avg
Panel avg: 160d · 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 144
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