Cleared Traditional

K031787 - SMITH & NEPHEW IUR MORCELLATION SYSTEM

K031787 is an FDA 510(k) clearance for SMITH & NEPHEW IUR MORCELLATION SYSTEM, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K031787 · Smith & Nephew, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 2003
Decision
175d
Days
Class 2
Risk

K031787 is an FDA 510(k) clearance for the SMITH & NEPHEW IUR MORCELLATION 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 December 2, 2003 after a review of 175 days - an extended review cycle.

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

FDA 510(k) Submission Details - K031787

510(k) Number K031787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date December 02, 2003
Days to Decision 175 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
15d slower than avg
Panel avg: 160d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K031787.
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc. · Oct 2004
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
K040390 · Stryker Endoscopy · May 2004
UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
K033113 · Richard Wolf Medical Instruments Corp. · Dec 2003
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
K022445 · Olympus Optical Co., Ltd. · Jan 2003
ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
K022480 · Acmi Corporation · Aug 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · Smith & Nephew, Inc. · Jan 2002