Data / Medical devices / China / Endoclot Plus Co., Ltd.
Endoclot Plus Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
Endoclot Plus Co., Ltd. is registered with the FDA (registration 3013155768) in Suzhou Jiangsu, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013155768
- Address
- Unit 101, B8 Building, 218 Xinghu Street Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone Suzhou Area, Suzhou Jiangsu, China, 215000
- Owner or operator
- EndoClot Plus Co., Ltd. (10052433)
- Roles
- Manufacturer
- First device listed
- February 15, 2017
- Registered through
- 2026
- Brand names listed
- EndoClot Air Compressor, EndoClot Air Compressor Connecting Tube, EndoClot Applicator, EndoClot PHS, EndoClot SIS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Compressor, Air, Portable | BTI | 2 | Manufacturer | accessdata.fda.gov |
| Hemostatic Device For Endoscopic Gastrointestinal Use | QAU | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Submucosal Injection Agent | PLL | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | 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 29, 2021 | K190677 | EndoClot | QAU | Substantially Equivalent | Endoclot Plus Co., Ltd. | accessdata.fda.gov |
| January 30, 2020 | K191254 | EndoClot | PLL | Substantially Equivalent | Endoclot Plus Co., Ltd. | accessdata.fda.gov |
| January 18, 2017 | K162197 | EndoClot | GCJ | Substantially Equivalent | Endoclot Plus Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Submucosal Injection Agent
- All makers of Compressor, Air, Portable
- All makers of Hemostatic Device For Endoscopic Gastrointestinal Use
- All makers of Tubing, Pressure And Accessories
Updated January 29, 2021. 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.