Skip to the page
Get started – free

Data / Medical devices / Accessories, Catheter, G-U

Accessories, Catheter, G-U (KNY): 20 FDA-registered makers in 7 countries

20 establishments in 7 countries are registered with the FDA to make Accessories, Catheter, G-U (product code KNY, Class 2, 21 CFR 876.5130). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 65 510(k) clearances under this code, the latest on August 5, 2026, and lists 3 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
KNY
Device class
2
Regulation
876.5130
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States9
Germany4
Mexico3
Monaco1
China1
Romania1
Ireland1

Makers of Accessories, Catheter, G-U

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
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2February 4, 2013000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer1September 21, 1994000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer1April 23, 1999000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer1September 21, 1994000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1April 25, 1995000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer1April 25, 1995000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer1May 24, 1995000api.fda.gov
Rocamed SamMONACO Monaco-Ville, MonacoManufacturer1September 7, 2018000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Conod Medical Shuyang Co., Ltd.Shuyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hennig Enterprises Europe S.R.L.Iasi, RomaniaContract manufacturer0000api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesSpecification 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
Lake Region Medical LimitedNEW ROSS Wexford, IrelandContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesSpecification developer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov

Updated August 5, 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.