K213194 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 June 23, 2022, 267 days after receiving the submission on September 29, 2021.
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 | K213194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | June 23, 2022 |
| Days to Decision | 267 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). |