510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240978Substantially Equivalent

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

Macrolux Medical Technology Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240978 is the FDA 510(k) clearance record for SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G), a class II device, cleared for MacroLux Medical Technology Co., Ltd. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 7 510(k) clearances for MacroLux Medical Technology Co., Ltd., from to . As of , FDA records show no recalls naming K240978.

Clearance record

Decision date
Received
(128 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
MacroLux Medical Technology Co., Ltd. 301, Bldg. 3, Namtai Inno Park In Guang Ming Ave., Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260