Data / Medical devices / China / Hunan Endoso Life Technology Co., Ltd
Hunan Endoso Life Technology Co., Ltd: FDA-registered device maker in XiangTan Hunan, China, 3 510(k) clearances
Hunan Endoso Life Technology Co., Ltd is registered with the FDA (registration 3030504644) in XiangTan Hunan, China. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 22, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030504644
- Address
- 4th floor, Building 10, Innovation and Entrepreneurship Center, No. 31, Dongfeng Road, Heping Street, XiangTan Hunan, China, 411100
- Owner or operator
- Hunan Endoso Life Technology Co., Ltd (10089503)
- Roles
- Manufacturer
- First device listed
- December 13, 2023
- Registered through
- 2026
- Brand names listed
- Endoscopic Camera System, P2-F1, P2-F2, P2-F3, P2-F4, P2-G1, P2-G2, P2-G3, P2-G4, Endoscopic Camera System, P2-H1, P2-H2, P2-H3, P2-H4, P2-I1, P2-I2, P2-I3, P2-I4, Endoscopic Camera System, P2-J1, P2-J2, P2-J3, P2-J4, P2-K1, P2-K2, P2-K3, P2-K4, Endoscopic Image Processor, P1-A, P1-B, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E, Endoscopic Image System, U400, U400-A, U400-B, U400-C, U400-D, Endoscopic Image System, U500, U500-A, U500-B, Endoscopic Light Source, HL2000-L1, HL2000-L1-N, Endoscopic Light Source, HL5000-L1, HL5000-L1-N and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Television, Endoscopic, Without Audio | FWF | 1 | Manufacturer | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 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 |
|---|---|---|---|---|---|---|
| January 22, 2025 | K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | FGB | Substantially Equivalent | Hunan Endoso Life Technology Co., Ltd. | accessdata.fda.gov |
| February 15, 2024 | K231107 | Bronchoscope System | EOQ | Substantially Equivalent | Hunan Endoso Life Technology Co., Ltd. | accessdata.fda.gov |
| October 16, 2023 | K231725 | Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | GCJ | Substantially Equivalent | Hunan Endoso Life Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Guidewire, Gastroenterology-Urology
- All makers of Camera, Television, Endoscopic, Without Audio
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Laparoscope, General & Plastic Surgery
Updated January 22, 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.