Cleared Traditional

K240978 - SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) (FDA 510(k) Clearance)

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

K240978 · MacroLux Medical Technology Co., Ltd. · Obstetrics & Gynecology device

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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.

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Submission Details

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.

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.