Incore Co., Ltd.
South KoreaFDA applicant, unverified FDA FEI 3017390965
- Devices
- 23
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Incore Co., Ltd. makes
Incore Co., Ltd. manufactures surgical and medical devices including laparoscopic graspers (CORE-CLIP, CORE-SNARE), a trocar (CORE-Trocar), a tissue injection tool (CORE-INJECTOR), and a hemostatic agent (Hemoblock_S) available in prescription and over-the-counter formulations. The CORE-SPORT is designed for sports medicine applications, likely for joint or soft tissue procedures.
The company’s portfolio includes Class II and Unclassified (U) devices, all of which are listed under the FDA’s 510(k) pathway. These devices are regulated under U.S. medical device laws, and the company is based in the United States.
Catalogue
Search and filter all 23 devicesCompany details
- FDA FEI number
- 3017390965
- DUNS number
- 690405835
- Address
- 11, Hyeoksin-daero 78-gil, Dong-gu, Daegu
- [email protected]
- Phone
- +821065095009
Frequently asked questions
How many devices does Incore Co., Ltd. have in the registry?
The registry currently lists 23 devices for Incore Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Incore Co., Ltd.'s devices?
Among its 23 most recently registered devices, Incore Co., Ltd. has devices listed in FDA 510(k) (6 devices) and FDA GUDID (17 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Incore Co., Ltd.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for Incore Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Incore Co., Ltd. in the registry?
The most recently registered devices listed for Incore Co., Ltd. include CORE-Trocar IC-TC05, CORE-Trocar IC-TC12, CORE-Trocar IC-TC02 and CORE-Trocar IC-TC03.