Data / Medical devices / United States / Wicki Medical, LLC
Wicki Medical, LLC: FDA-registered device maker in Pittsburgh, PA, United States, 1 510(k) clearance
Wicki Medical, LLC is registered with the FDA (registration 3021284635) in Pittsburgh, PA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 11, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021284635
- Address
- 1220 Ridgewood DR, Pittsburgh, PA, United States, 15241
- Owner or operator
- Wicki Medical, LLC (10083927)
- Roles
- Complaint file establishment
- First device listed
- December 30, 2021
- Registered through
- 2026
- Brand names listed
- Adinizer, Smart Kit, Smart Kit Basic, Smart Kit Pro, Smart Lock, Smart Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filters, Cell Collection, Tissue Processing | KET | 1 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment | accessdata.fda.gov |
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Suction, Lipoplasty | MUU | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| March 11, 2021 | K202443 | Smart Kit Basic, Smart Kit Pro | MUU | Substantially Equivalent | Bsl Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Filters, Cell Collection, Tissue Processing
- All makers of System, Suction, Lipoplasty
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Lipoaspirate Washing System For Aesthetic Body Contouring
Updated March 11, 2021. 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.