Data / Medical devices / Israel / Ark Surgical
Ark Surgical: FDA-registered device maker in Nazareth Haifa, Israel, 2 510(k) clearances
Ark Surgical is registered with the FDA (registration 3025598220) in Nazareth Haifa, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 15, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3025598220
- Address
- 13 Wadi El Haj, Nazareth Haifa, Israel, 1603611
- Owner or operator
- ProMedoss (10086954)
- Roles
- Manufacturer
- First device listed
- December 27, 2022
- Registered through
- 2027
- Brand names listed
- LapBox Power Tissue Containment System, LapBox Tissue Containment Removal System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Containment System, Laparoscopic Power Morcellation, With Instrument Port | PMU | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 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 |
|---|---|---|---|---|---|---|
| April 15, 2025 | K250212 | LapBox Power Tissue Containment System | PMU | Substantially Equivalent | Ark Surgical | accessdata.fda.gov |
| August 25, 2022 | K221365 | LapBox Tissue Containment Removal System | GCJ | Substantially Equivalent | Ark Surgical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Containment System, Laparoscopic Power Morcellation, With Instrument Port
Updated April 15, 2025. 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.