Data / Medical devices / United States / Geodis
Geodis: FDA-registered device maker in Sparks, NV, United States, 16 510(k) clearances
Geodis is registered with the FDA (registration 3008087383) in Sparks, NV, United States. It lists 10 device types. The FDA files 16 510(k) clearances under its listings, the newest dated December 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008087383
- Address
- 450 Lillard Drive, Sparks, NV, United States, 89434
- Owner or operator
- GEODIS (10030802)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- November 12, 2009
- Registered through
- 2026
- Brand names listed
- AERA WITH VENT CAP, Hermetic Large Style Ventricular Catheter Set, INSPIRA AIR Balloon Dilation System, LUMA SENTRY, MoniTorr ICP¿ External CSF Drainage and Monitoring System with Patient Line One Way Valve, RELIEVA TRACT, SMS 1 PACK US - PCCR, SPINPLUS 3-GUIDE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon, Nasal Airway | QGK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bronchoscope Accessory | KTI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Sinus | KAM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Dermal Replacement | MDD | 3 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound And Burn, Interactive | MGR | 3 | Contract manufacturer | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Eustachian Tube Balloon Dilation Device | PNZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | Repackager or relabeler | 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 13, 2023 | K230742 | ACCLARENT AERA Eustachian Tube Dilation System | PNZ | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| July 20, 2022 | K221037 | TruDi Shaver Blade | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| August 12, 2020 | K201174 | TruDi Curette | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| March 23, 2020 | K193453 | TruDi Probe | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| April 19, 2019 | K183090 | Relieva Tract Balloon Dilation System | QGK | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| July 20, 2018 | K180948 | TruDi NAV Suction Instruments | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| September 5, 2017 | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| February 12, 2016 | K153341 | Relieva Scout Multi-Sinus Dilation System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| April 22, 2015 | K143541 | Relieva SpinPlus Balloon Sinuplasty System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| February 20, 2014 | K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| March 31, 2011 | K110218 | INSPIRA AIR BALLOON DILATION SYSTEM | KTI | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| September 28, 2007 | K071845 | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | KAM | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| February 26, 2003 | K030289 | HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N | JXG | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| August 23, 2002 | K022554 | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | JXG | Substantially Equivalent | Integra Neurosciences | accessdata.fda.gov |
| February 18, 1982 | K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. | JXG | Substantially Equivalent | American Heyer Schulte | accessdata.fda.gov |
| August 30, 1976 | K760502 | VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH. | JXG | Substantially Equivalent | Joe W. Utt | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Ent Manual Surgical
- All makers of Device, Dermal Replacement
- All makers of Dressing, Wound And Burn, Interactive
- All makers of Ear, Nose, And Throat Stereotaxic Instrument
- All makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- All makers of Shunt, Central Nervous System And Components
Updated December 13, 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.