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Data / Medical devices / Catheter, Suprapubic (And Accessories)

Catheter, Suprapubic (And Accessories) (KOB): 15 FDA-registered makers in 5 countries

15 establishments in 5 countries are registered with the FDA to make Catheter, Suprapubic (And Accessories) (product code KOB, Class 2, 21 CFR 876.5090). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on November 1, 2024, 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
KOB
Device class
2
Regulation
876.5090
Medical specialty
Gastroenterology, Urology
Implant
Yes

Makers by country

CountryMakers
United States9
United Kingdom3
Taiwan1
Mexico1
China1

Makers of Catheter, Suprapubic (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
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer7January 18, 2019020api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer7January 18, 2019000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2February 7, 1997000api.fda.gov
Applied Medical Technology, Inc.Brecksville, OH, United StatesManufacturer1November 1, 2024000api.fda.gov
Femcare Ltd.ROMSEY Hampshire, United KingdomSpecification developer1October 25, 1988000api.fda.gov
Fortune Medical Instrument Corp.Taoyuan City, TaiwanContract manufacturer, Manufacturer1March 4, 2002000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer1September 19, 2001000api.fda.gov
Mediplus Ltd.HIGH WYCOMBE, BUCKS Buckinghamshire, United KingdomComplaint file establishment, Exporter to the US, Manufacturer, Specification developer1January 17, 2014000api.fda.gov
Swan Valley Medical, IncorporatedDenver, CO, United StatesComplaint file establishment, Manufacturer1October 26, 2012000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1October 25, 1988000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
The Flume Catheter Company LtdFarnham Surrey, United KingdomSpecification developer0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaContract manufacturer0000api.fda.gov

Updated November 1, 2024. 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.