Data / Medical devices / Israel / Endogi Medical, Ltd.
Endogi Medical, Ltd.: FDA-registered device maker in Nazareth Northern, Israel, 2 510(k) clearances
Endogi Medical, Ltd. is registered with the FDA (registration 3016463905) in Nazareth Northern, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 27, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016463905
- Address
- Wadi El Haj 13, Nazareth Northern, Israel, 17111
- Owner or operator
- EndoGI Medical, Ltd. (10078370)
- Roles
- Manufacturer
- First device listed
- October 20, 2020
- Registered through
- 2026
- Brand names listed
- EndoGI S-Path Biliary Stent System 10F (3.3mm) x 120, EndoGI S-Path Biliary Stent System 10F (3.3mm) x 60, EndoGI S-Path Biliary Stent System 10F (3.3mm) x 90, Specialized S-Path Delivery System for 10Fr Pigtail Stent, X-Path Pre-loaded RX-OTW Double Biliary Stents System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 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 27, 2023 | K232596 | EndoGI S-Path Biliary Stent System | FGE | Unknown | Endogi Medical, Ltd. | accessdata.fda.gov |
| June 26, 2020 | K193600 | EndoGI Biliary Stent System | FGE | Substantially Equivalent | Endogi Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 27, 2023. 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.