Data / Medical devices / United States / Intuit Medical Products, LLC
Intuit Medical Products, LLC: FDA-registered device maker in Lawrenceville, GA, United States, 3 510(k) clearances
Intuit Medical Products, LLC is registered with the FDA (registration 3012422952) in Lawrenceville, GA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012422952
- Address
- 1990 Riverside Parkway, Lawrenceville, GA, United States, 30043
- Owner or operator
- Intuit Medical Products, LLC (10050055)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- October 8, 2015
- Registered through
- 2026
- Brand names listed
- ClearPath Nasal Balloon Catheter, ClearPath Nasal Balloon Guide Spatula, ClearPath Nasal Balloon System, Dillard Airway Balloon Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope Accessory | KTI | 2 | Specification developer | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spatula, Surgical, General & Plastic Surgery | GAF | 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 |
|---|---|---|---|---|---|---|
| January 3, 2020 | K181546 | Dillard Nasal Balloon Catheter | LRC | Substantially Equivalent | Intuit Medical Products, LLC | accessdata.fda.gov |
| July 27, 2016 | K153484 | Dillard Airway Dilatation System | KTI | Substantially Equivalent | Intuit Medical Products, LLC | accessdata.fda.gov |
| August 27, 2015 | K143738 | DSS Sinusplasty Balloon Catheter | LRC | Substantially Equivalent | Intuit Medical Products, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope Accessory
- All makers of Instrument, Ent Manual Surgical
- All makers of Spatula, Surgical, General & Plastic Surgery
- All makers of Forceps, Ent
Updated January 3, 2020. 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.