Cleared Traditional

SeleneView? Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

K240978 · MacroLux Medical Technology Co., Ltd. · Obstetrics & Gynecology
Aug 2024
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K240978 is an FDA 510(k) clearance for the SeleneView? Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G), a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by MacroLux Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 16, 2024, 128 days after receiving the submission on April 10, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K240978 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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