Cleared Traditional

K161763 - Smith & Nephew TRUCLEAR ULTRA Mini Tiss...

K161763 is the FDA 510(k) clearance for Smith & Nephew TRUCLEAR ULTRA Mini Tiss... by Smith & Nephew, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K161763 · Smith & Nephew, Inc. · Obstetrics & Gynecology device
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Nov 2016
Decision
148d
Days
Class 2
Risk

K161763 is an FDA 510(k) clearance for the Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device. 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 November 22, 2016 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K161763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2016
Decision Date November 22, 2016
Days to Decision 148 days
Submission Type Traditional
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
12d faster than avg
Panel avg: 160d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K161763.
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
K171113 · Lina Medical Aps · Jan 2018
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K172566 · Hologic, Inc. · Sep 2017
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
K170660 · CooperSurgical, Inc. · Jul 2017
Symphion Endoscope and Symphion Cervical Sheath
K160751 · Boston Scientific · Jun 2016
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · Hologic, Inc. · Nov 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · Smith & Nephew, Inc. · Sep 2015