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Data / Medical devices / Hysteroscope Accessories

Hysteroscope Accessories (NWW): 46 FDA-registered makers in 9 countries

46 establishments in 9 countries are registered with the FDA to make Hysteroscope Accessories (product code NWW, Class 1, 21 CFR 884.1690). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
NWW
Device class
1
Regulation
884.1690
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
Germany16
China12
United States11
Japan2
India1
Costa Rica1
Switzerland1
Denmark1
Poland1

Makers of Hysteroscope Accessories

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer0000api.fda.gov
Axora Medical, Inc.Sunnyvale, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Anhui Shiyin Photoelectric Instrument Co., Ltd.Suzhou Anhui, ChinaManufacturer, Specification developer0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Berger Surgical Medical Products GmbHNeuhausen ob Eck Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Dausch Medizintechnik GmbHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Guangzhou Red Pine Medical Instrument Co.,ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong MacroLux Medical Technology Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesSpecification developer0000api.fda.gov
Hangzhou Fushan Medical Appliance Co., Ltd.Hangzhou City Zhejiang, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Heager GmbHHAAN North Rhine-Westphalia, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Hologic Surgical Products Costa Rica, S.R.L.El Coyol Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Jiangsu Jiyuan Medical Technology Co., Ltd.Taizhou Jiangsu, ChinaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer0000api.fda.gov
LiNA Medical AGRoot D4 Luzern, SwitzerlandExporter to the US, Manufacturer0000api.fda.gov
LiNA Medical ApSNaerum Hovedstaden, DenmarkSpecification developer0000api.fda.gov
LiNA Medical Polska sp. z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Macrolux Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Minerva Surgical, Inc.Santa Clara, CA, United StatesManufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
OBP Medical CorporationLawrence, MA, United StatesSpecification developer0000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer0000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Origyn Medical Technology (hangzhou) Co., LtdHangzhou Zhejiang, ChinaManufacturer, Specification developer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Strub Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Suzhou Acuvu Medical Technology Co., Ltd.Suzhou Jiangsu, ChinaSpecification developer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Tonglu Wanhe Medical Instrument Co., Ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Trokamed GMBHGEISINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Xuzhou AKX Electronic Science and Technology Co., Ltd.Xuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhuji Pengtian Medical Instrument Co.,Ltd.Zhuji Zhejiang, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.