Data / Medical devices / South Korea / Endorobotics Co., Ltd.
Endorobotics Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
Endorobotics Co., Ltd. is registered with the FDA (registration 3044545674) in Seoul, South Korea. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 24, 2025. Registered through 2026. 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.
- FDA registration number
- 3044545674
- Address
- Room No., 9F, 14F, 15F, 57, Daehak-ro, Jongno-gu, Seoul, South Korea, 03082
- Owner or operator
- EndoRobotics Co., Ltd. (10096160)
- Roles
- Manufacturer
- First device listed
- July 13, 2026
- Registered through
- 2026
- Brand names listed
- Articulated Basic Gripper G (AB-G-01), Articulated Dual Gripper G (AD-G-01), Controller A (R-JA-002), Controller B (R-JB-002), R-Power Cable (North America) (PC-R-002), ROBOPERA (ER-R-002), ROBOPERA (ER-R-003), ROBOPERA Accessories (R-AC-001) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Manufacturer | accessdata.fda.gov |
| Gastroscope And Accessories, Flexible/Rigid | FDS | 2 | Manufacturer | accessdata.fda.gov |
| System, Surgical, Computer Controlled Instrument | NAY | 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 |
|---|---|---|---|---|---|---|
| September 24, 2025 | K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | FDF | Substantially Equivalent | Endorobotics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Colonoscope And Accessories, Flexible/Rigid
- All makers of Gastroscope And Accessories, Flexible/Rigid
- All makers of System, Surgical, Computer Controlled Instrument
Updated September 24, 2025. 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.