The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for Hd Mediastinoscope.
| Device ID | K213194 |
| 510k Number | K213194 |
| Device Name: | HD Mediastinoscope |
| Classification | Mediastinoscope, Surgical |
| Applicant | Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Contact | Alita McElroy |
| Correspondent | Alita McElroy Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 |
| Product Code | EWY |
| CFR Regulation Number | 874.4720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-06-23 |