K181240 is an FDA 510(k) clearance for the Rhino-Laryngo Fiberscope Olympus ENF-GP2. This device is classified as a Nasopharyngoscope (flexible Or Rigid) (Class II - Special Controls, product code EOB).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 4, 2018, 147 days after receiving the submission on May 10, 2018.
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 | K181240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2018 |
| Decision Date | October 04, 2018 |
| Days to Decision | 147 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). |