K171402 is an FDA 510(k) clearance for the KARL STORZ Slim Nasopharyngolaryngoscope. This device is classified as a Nasopharyngoscope (flexible Or Rigid) (Class II - Special Controls, product code EOB).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on February 2, 2018, 266 days after receiving the submission on May 12, 2017.
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 | K171402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2017 |
| Decision Date | February 02, 2018 |
| Days to Decision | 266 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). |