Data / Medical devices / Ireland / Palliare
Palliare: FDA-registered device maker in Galway Galway(County), Ireland, 3 510(k) clearances
Palliare is registered with the FDA (registration 3017590240) in Galway Galway(County), Ireland. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017590240
- Address
- Palliare, Galway Business Park Dangan, Galway Galway(County), Ireland, H91P2DK
- Owner or operator
- Palliare (10078788)
- Roles
- Manufacturer
- First device listed
- November 5, 2020
- Registered through
- 2026
- Brand names listed
- END 200M, END 200S, EVA15, EVA5, EndoTrap, Erbe ECO2 plus, LAP 100, LAP 200 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Evacuator, Gastro-Urology | KQT | 2 | Manufacturer | accessdata.fda.gov |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | 2 | Manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 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 |
|---|---|---|---|---|---|---|
| May 2, 2024 | K232902 | EVA15 insufflator | HIF | Substantially Equivalent | Palliare , Ltd. | accessdata.fda.gov |
| March 24, 2023 | K230474 | EVA5 Insufflator | FCX | Substantially Equivalent | Palliare , Ltd. | accessdata.fda.gov |
| October 21, 2020 | K202799 | EVA15 | HIF | Substantially Equivalent | Palliare , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Insufflator, Laparoscopic
- All makers of Evacuator, Gastro-Urology
- All makers of Insufflator, Automatic Carbon-Dioxide For Endoscope
- All makers of Tube, Smoke Removal, Endoscopic
Updated May 2, 2024. 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.