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Data / Medical devices / Enteroscope And Accessories

Enteroscope And Accessories (FDA): 15 FDA-registered makers in 3 countries

15 establishments in 3 countries are registered with the FDA to make Enteroscope And Accessories (product code FDA, Class 2, 21 CFR 876.1500). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on May 1, 2026, 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 JapanWatch this device
Product code
FDA
Device class
2
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
Japan10
United States4
China1

Makers of Enteroscope And 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
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanComplaint file establishment, Manufacturer, Specification developer7June 13, 2024000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanContract manufacturer, Manufacturer6January 11, 2023000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer1March 25, 2008000api.fda.gov
Aspero Medical, Inc.Westminster, CO, United StatesSpecification developer1May 1, 2026000api.fda.gov
FUJIFILM Healthcare Americas CorporationLexington, MA, United StatesManufacturer1September 26, 2025000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer1March 25, 2008000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer1March 25, 2008000api.fda.gov
Spirus Medical, LLCW Bridgewater, MA, United StatesSpecification developer1August 4, 2006000api.fda.gov
Dalian Create Medical Products Co., LTD.Dalian Liaoning, ChinaContract manufacturer0000api.fda.gov
FUJI SYSTEMS CORPORATION, Shin-Shirakawa PlantShirakawa Fukushima, JapanContract manufacturer0000api.fda.gov
FUJI SYSTEMS CORPORATION, Shirakawa PlantNishi Shirakawa Gun Fukushima, JapanContract manufacturer0000api.fda.gov
Fujifilm CorporationASHIGARAKAMI-GUN Kanagawa, JapanSpecification developer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Hanamaki OfficeHANAMAKI-SHI Iwate, JapanManufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Tochigichizuka PlantChizuka, Tochigi, JapanContract manufacturer0000api.fda.gov

Updated May 1, 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.