Data / Medical devices / Israel / Plasmatica
Plasmatica: FDA-registered device maker in RaAnana Tel Aviv, Israel, 1 510(k) clearance
Plasmatica is registered with the FDA (registration 3025306172) in RaAnana Tel Aviv, Israel. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025306172
- Address
- Hataasiya 25, RaAnana Tel Aviv, Israel, 4365413
- Owner or operator
- Plasmatica (10086673)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 1, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Anti Fog Solution And Accessories, Endoscopy | OCT | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer, Repackager or relabeler, Specification developer | 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 12, 2022 | K221533 | Plasma Shield | GCJ | Substantially Equivalent | Plasmatica, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Anti Fog Solution And Accessories, Endoscopy
Updated September 12, 2022. 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.