Data / Medical devices / South Korea / Insung Medical Co., Ltd.
Insung Medical Co., Ltd.: FDA-registered device maker in WONJU-SI Gangwon, South Korea, 1 510(k) clearance
Insung Medical Co., Ltd. is registered with the FDA (registration 3013023209) in WONJU-SI Gangwon, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 28, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013023209
- Address
- 168, Gieopdosi-Ro, Jijeong-Myeon, WONJU-SI Gangwon, South Korea, 26354
- Owner or operator
- INSUNG MEDICAL CO., LTD. (10078318)
- Roles
- Manufacturer
- First device listed
- October 19, 2020
- Registered through
- 2026
- Brand names listed
- ANKOR endobronchial tube (Models: ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R), ANKOR endobronchial tube (Models: HBC33L, HBC35L, HBC37L, HBC39L, HBC33R, HBC35R, HBC37R, HBC39R), Human-broncho endobronchial tube (Models: HBC33L, HBC35L, HBC37L, HBC39L, HBC33R, HBC35R, HBC37R, HBC39R), Suction Catheter (Models: Y-110, Y-112)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 28, 2020 | K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | CBI | Substantially Equivalent | Insung Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- All makers of Catheters, Suction, Tracheobronchial
Updated December 28, 2020. 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.