Cleared Traditional

K240978 - SeleneView Single-Use Digital Hysterosc...

K240978 is an FDA 510(k) clearance for SeleneView Single-Use Digital Hysterosc..., manufactured by MacroLux Medical Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K240978 · MacroLux Medical Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
128d
Days
Class 2
Risk

K240978 is an FDA 510(k) clearance for the SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by MacroLux Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 16, 2024 after a review of 128 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 MacroLux Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K240978

510(k) Number K240978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2024
Decision Date August 16, 2024
Days to Decision 128 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
32d faster than avg
Panel avg: 160d · This submission: 128d
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 109
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K240978.
ARMI® Endoscopic Video Image Processor (JY-MIP-3000)
K252793 · Jiangsu Jiyuan Medical Technology Co., Ltd. · Dec 2025
SPY Cystoscope/Hysteroscope
K252012 · Stryker Endoscopy · Jul 2025
RZ Resectoscope System
K243382 · Rz Medizintechnik GmbH · Jun 2025
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241987 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Aug 2024
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
K240401 · Origyn Medical Technology (Hangzhou) Co., Ltd. · Jul 2024
HTx Disposable Hysteroscope System
K231260 · Suzhou AcuVu Medical Technology Co., Ltd. · Mar 2024