Cleared Traditional

TruClear Elite Hysteroscope (K180496) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180496 · Covidien · Obstetrics & Gynecology device
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Aug 2018
Decision
184d
Days
Class 2
Risk

K180496 is an FDA 510(k) clearance for the TruClear Elite Hysteroscope. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on August 29, 2018 after a review of 184 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.

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Submission Details

510(k) Number K180496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2018
Decision Date August 29, 2018
Days to Decision 184 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
24d slower than avg
Panel avg: 160d · This submission: 184d
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 95
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K180496.
Endosee System
K183020 · CooperSurgical, Inc. · Jan 2019
Polygon Resection Device
K182675 · Polygon Medical, Inc. · Jan 2019
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
K182006 · Hologic, Inc. · Dec 2018
MyoSure XL Tissue Removal Device for Fluent
K181974 · Hologic, Inc. · Aug 2018
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
K180752 · Corinth Medtech, Inc. · Jul 2018
HSW Resection Instruments
K173070 · Henke-Sass, Wolf GmbH · Jun 2018