Decision Date2024-08-16
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) is the device name listed in this FDA 510(k) record. The listed applicant is MacroLux Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K240978. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)?
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is MacroLux Medical Technology Co., Ltd.. The 510(k) number is K240978.
When did SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) receive FDA 510(k) clearance?
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) received FDA 510(k) clearance on 2024-08-16, under 510(k) number K240978.
Who is the listed applicant for SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)?
The FDA 510(k) record lists MacroLux Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)?
The FDA product code for SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) is HIH.
Other records listing MacroLux Medical Technology Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)K250452CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)K233779LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)K231774CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) View all 7 devices →
Related Devices (Code: HIH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.