K202272 is an FDA 510(k) clearance for the HD Mediastinoscope. This device is classified as a Mediastinoscope, Surgical (Class II - Special Controls, product code EWY).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on May 11, 2021, 273 days after receiving the submission on August 11, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4720. 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 | K202272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2020 |
| Decision Date | May 11, 2021 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWY — Mediastinoscope, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4720 |
| 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). |