Data / Medical devices / United States / Pivot - Edm
Pivot - Edm: FDA-registered device maker in La Vista, NE, United States, 1 510(k) clearance
Pivot - Edm is registered with the FDA (registration 3014903258) in La Vista, NE, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014903258
- Address
- 12202 Cary Circle, La Vista, NE, United States, 68128
- Owner or operator
- Pivot - EDM (10061153)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- August 30, 2019
- Registered through
- 2026
- Brand names listed
- 5020 Console; 5025 Console, ASP-PUMP-120, PAL Aspiration Pump, 115V, ASP-PUMP-240, PAL Aspiration Pump, 230V, ASP-UI, PAL Aspiration Pump Console, Otoscope, Otoscope - WiscMed Wispr, PAL 7020 Console, Platform, Force-Measuring and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Contract manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Contract manufacturer | accessdata.fda.gov |
| Platform, Force-Measuring | KHX | 1 | Contract manufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Contract manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 30, 2024 | K242804 | PAL Aspiration System | QPB | Substantially Equivalent | Microaire Surgical Instruments, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Suction, Lipoplasty For Removal
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Otoscope
- All makers of Platform, Force-Measuring
Updated December 30, 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.