K243639 is an FDA 510(k) clearance for the Portare System (FA-001). This device is classified as a Nasopharyngoscope (flexible Or Rigid) (Class II - Special Controls, product code EOB).
Submitted by Grumpy Innovation, Inc. (Sioux Falls, US). The FDA issued a Cleared decision on June 5, 2025, 192 days after receiving the submission on November 25, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4760. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K243639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2024 |
| Decision Date | June 05, 2025 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EOB - Nasopharyngoscope (flexible Or Rigid) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4760 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |