Data / Medical devices / United States / EmCyte Corporation
EmCyte Corporation: FDA-registered device maker in Fort Myers, FL, United States, 5 510(k) clearances
EmCyte Corporation is registered with the FDA (registration 1066491) in Fort Myers, FL, United States. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1066491
- FEI number
- 3003429569
- Address
- 4331 Veronica S. Shoemaker Blvd., Fort Myers, FL, United States, 33916
- Owner or operator
- EmCyte Corporation (9047034)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 25, 2001
- Registered through
- 2027
- Brand names listed
- ABSOLUTEBMC CONCENTRATING SYSTEM, ABSOLUTEPRP CONCENTRATING SYSTEM, ASPIRE Bone Marrow Harvesting System, BONE GRAFT SYRINGE HOLDER, CORE Ultrafiltration System, Centrepid Platelet Concentrator, EMSTYLE SKIN VITALIZE, EXECUTIVE SERIES CENTRIFUGE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | 1 | Manufacturer | accessdata.fda.gov |
| Centrifuge, Blood-Bank For In Vitro Diagnostic Use | KSO | 1 | Specification developer | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Manufacturer | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Research Use Only/Hematology Devices | OTQ | N | Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty | MUU | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Filter, Membrane | JRL | 1 | 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 |
|---|---|---|---|---|---|---|
| August 11, 2023 | K230420 | Dr. pen Microneedling System | QAI | Substantially Equivalent | Guangzhou Ekai Electronic Technology Co., Ltd. | accessdata.fda.gov |
| November 7, 2019 | K191564 | Progenikine Concentrating System 25 mL System | MUU | Substantially Equivalent | Emcyte Corporation | accessdata.fda.gov |
| May 30, 2019 | K183205 | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System | JQC | Unknown | Emcyte Corporation | accessdata.fda.gov |
| June 20, 2007 | K070666 | GENESISCS COMPONENT CONCENTRATING SYSTEM | JQC | Substantially Equivalent | Perfusion Partners & Assoc., Inc. | accessdata.fda.gov |
| July 2, 2003 | K024080 | SECQUIRE CELL SEPARATOR | JQC | Substantially Equivalent | Perfusion Partners & Assoc., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of Unit, Filter, Membrane
- All makers of System, Suction, Lipoplasty
- All makers of Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Updated August 11, 2023. 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.