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Data / Medical devices / South Korea / Sewoon Medical Co., Ltd.

Sewoon Medical Co., Ltd.: FDA-registered device maker in Cheonan-si Chungnam, South Korea, 6 510(k) clearances

Sewoon Medical Co., Ltd. is registered with the FDA (registration 3000247987) in Cheonan-si Chungnam, South Korea. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 17, 2014. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Sewoon Medical Co., Ltd.
FDA registration number
3000247987
Address
60, Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si Chungnam, South Korea, 31061
Owner or operator
SEWOON Medical Co., Ltd. (9036109)
Roles
Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer
First device listed
January 8, 1999
Registered through
2026
Brand names listed
Barovac, Bonastent, Temp Foley

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Complaint file establishment, Exporter to the US, Manufactureraccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov
Prosthesis, EsophagealESW2Manufactureraccessdata.fda.gov
Prosthesis, Tracheal, ExpandableJCT2Manufactureraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Manufactureraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov
Support, Breathing TubeJAY1Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling CatheterFCN2Contract manufacturer, Contract sterilizer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 17, 2014K140472BONASTENT TRACHEAL / BRONCHIALJCTSubstantially EquivalentEndochoice, Inc.accessdata.fda.gov
June 16, 2014K140760BONASTENT BILIARYFGEUnknownEndochoice, Inc.accessdata.fda.gov
March 24, 2010K093003BONASTENT BILIARYFGEUnknownEndochoice, Inc.accessdata.fda.gov
February 22, 2010K092144BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFRESWSubstantially EquivalentEndochoice, Inc.accessdata.fda.gov
September 23, 2002K0222873T/SEWOON TEMPERATURE SENSING FOLEY CATHETERSEZLSubstantially Equivalent3t Medical Systems, LLCaccessdata.fda.gov
February 15, 2002K013276ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)EZLSubstantially EquivalentSewoon Medical Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 17, 2014. 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.