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Data / Medical devices / Insufflator, Endoscopic Vessel Harvesting

Insufflator, Endoscopic Vessel Harvesting (OSV): 18 FDA-registered makers in 6 countries

18 establishments in 6 countries are registered with the FDA to make Insufflator, Endoscopic Vessel Harvesting (product code OSV, Class 2, 21 CFR 884.1730). 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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
OSV
Device class
2
Regulation
884.1730
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States7
Germany5
Thailand2
Japan2
Czechia1
Switzerland1

Makers of Insufflator, Endoscopic Vessel Harvesting

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
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Infus Medical (thailand) Co., Ltd.Amphoe Muang Samutprakarn Samut Prakan, ThailandContract manufacturer, Contract sterilizer0000api.fda.gov
Infus Medical Co., Ltd.Khon Kaen Province, ThailandContract manufacturer0000api.fda.gov
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler0000api.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. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Lexion Medical, LLC.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Novanta Medical S.R.O.Prelouc Pardubicky Kraj, CzechiaContract manufacturer, Manufacturer0000api.fda.gov
Northgate Technologies Inc.Elgin, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Novanta Medical GmbHLUDWIGSSTADT Bavaria, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Novanta Medical GmbHBerlin, GermanySpecification developer0000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer0000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer0000api.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.