Data / Medical devices / Australia / Qlicksmart Pty., Ltd.
Qlicksmart Pty., Ltd.: FDA-registered device maker in WEST END, BRISBANE Queensland, Australia, 2 510(k) clearances
Qlicksmart Pty., Ltd. is registered with the FDA (registration 3003537565) in WEST END, BRISBANE Queensland, Australia. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 22, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003537565
- Address
- Level 1,148 Boundary Street, WEST END, BRISBANE Queensland, Australia, 4101
- Owner or operator
- QLICKSMART PTY., LTD. (9035134)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 19, 2005
- Registered through
- 2027
- Brand names listed
- BladeFLASK, BladeFlask EVO, BladeFlask EVO Blade Remover, BladeFlask PLUS, BladeFlask UNIVERSAL, BladeNeedleSYSTEM, CheckCLIP, Qlicksmart Ampoule Opener and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Container, Sharps | MMK | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Label Or Tag, Sterile | LYV | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| June 22, 2022 | K213274 | Qlicksmart BladeFlask UNIVERSAL | MMK | Substantially Equivalent | Qlicksmart Pty , Ltd. | accessdata.fda.gov |
| November 6, 1998 | K983367 | QLICKSMART | MMK | Substantially Equivalent | Handren Assoc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Needle, Suturing, Disposable
- All makers of Blade, Scalpel
- All makers of Container, Sharps
- All makers of Label Or Tag, Sterile
Updated June 22, 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.