Cleared Traditional

K240401 - ClearVision Single Use Hysteroscope & I...

K240401 is an FDA 510(k) clearance for ClearVision Single Use Hysteroscope & I..., manufactured by Origyn Medical Technology (Hangzhou) Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K240401 · Origyn Medical Technology (Hangzhou) Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
168d
Days
Class 2
Risk

K240401 is an FDA 510(k) clearance for the ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, E.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Origyn Medical Technology (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 26, 2024 after a review of 168 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 Origyn Medical Technology (Hangzhou) Co., Ltd. devices

FDA 510(k) Submission Details - K240401

510(k) Number K240401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2024
Decision Date July 26, 2024
Days to Decision 168 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 160d · This submission: 168d
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 K240401.
RZ Resectoscope System
K243382 · Rz Medizintechnik GmbH · Jun 2025
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
K240978 · MacroLux Medical Technology Co., Ltd. · Aug 2024
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241987 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Aug 2024
HTx Disposable Hysteroscope System
K231260 · Suzhou AcuVu Medical Technology Co., Ltd. · Mar 2024
Endoscopic Video Image Processor, Single-Use Video Hysteroscope
K232003 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Feb 2024
SPY Cystoscope/Hysteroscope
K233635 · Stryker Endoscopy · Feb 2024