Cleared Special

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) (K192278) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192278 · Uvision360, Inc. · Obstetrics & Gynecology device
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Nov 2019
Decision
71d
Days
Class 2
Risk

K192278 is an FDA 510(k) clearance for the Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Shea.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Uvision360, Inc. (Raleigh, US). The FDA issued a Cleared decision on November 1, 2019 after a review of 71 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 Uvision360, Inc. devices

Submission Details

510(k) Number K192278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2019
Decision Date November 01, 2019
Days to Decision 71 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
89d faster than avg
Panel avg: 160d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

MethodSense, Inc.
Rita King

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 93
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K192278.
Resectr Tissue Resection Device
K191538 · Boston Scientific Corporation · Jan 2020
Aveta Disposable Hysteroscope
K192100 · Meditrina, Inc. · Dec 2019
Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
K190797 · Reed Medical (Zhejiang) Co., Ltd. · Nov 2019
Aveta System
K191958 · Meditrina, Inc. · Oct 2019
Omni Hysteroscope, Omni Lok cervical seal
K191281 · Hologic, Inc. · Aug 2019
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
K190827 · Uvision360, Inc. · Jun 2019