Data / Medical devices / United States / Silq Technologies Corporation
Silq Technologies Corporation: FDA-registered device maker in Sunny Isles Beach, FL, United States, 1 510(k) clearance
Silq Technologies Corporation is registered with the FDA (registration 3014650073) in Sunny Isles Beach, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 21, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014650073
- Address
- 323 Sunny Isles Blvd. 7th Floor, Sunny Isles Beach, FL, United States, 33160
- Owner or operator
- Silq Technologies Corporation (10077941)
- Roles
- Manufacturer
- First device listed
- October 12, 2020
- Registered through
- 2026
- Brand names listed
- 2-Way 100% Silicone, 14Fr X 10ml, ClearTract SPT Catheter, 2-Way 100% Silicone, 16Fr X 10ml, ClearTract SPT Catheter, 2-Way 100% Silicone, 16Fr X 5ml, ClearTract SPT Catheter, 2-Way 100% Silicone, 18Fr X 10ml, ClearTract SPT Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 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 21, 2020 | K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc | EZL | Substantially Equivalent | Pathway, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 21, 2020. 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.