Data / Medical devices / Israel / Limaca Medical Ltd
Limaca Medical Ltd: FDA-registered device maker in Ein Ha Emeq Haifa, Israel, 1 510(k) clearance
Limaca Medical Ltd is registered with the FDA (registration 3029779285) in Ein Ha Emeq Haifa, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029779285
- Address
- 3 Ha' Rimon st, Regev Bldg. Mevo Carmel High Tech Park, Ein Ha Emeq Haifa, Israel, 1925000
- Owner or operator
- Limaca medical Ltd (10088881)
- Roles
- Manufacturer
- First device listed
- October 18, 2023
- Registered through
- 2026
- Brand names listed
- PRECISION GI 20GA Motorized EUS Biopsy Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 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 |
|---|---|---|---|---|---|---|
| August 28, 2023 | K231422 | Precision GI | FCG | Substantially Equivalent | Limaca Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 28, 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.