HD Mediastinoscope
FDA 510(k) K213194 · Karl Storz Endoscopy America, Inc.
510(k) numberK213194
Submission
- Device name
- HD Mediastinoscope
- Applicant
- Karl Storz Endoscopy America, Inc.
El Segundo, CA, US - Received
- September 29, 2021
- Decision date
- June 23, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EWY – Mediastinoscope, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4720
- Specialty
- Ear, Nose, Throat
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).
Other 510(k)s with product code EWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260003 | KARL STORZ Mediastinoscopes and InstrumentsEWY · Traditional | Karl Storz SE & CO. KG | 03/02/2026SE |
| K202272 | HD MediastinoscopeEWY · Traditional | Karl Storz Endoscopy America, Inc. | 05/11/2021SE |
| K170757 | Aegis Transit SystemEWY · Traditional | Boston-Biomedical Associates | 07/14/2017SE |
| K160171 | Illuminated Mediastinal Access PortEWY · Special | Aegis Surgical, Ltd. | 02/26/2016SE |
| K141622 | Illuminated MediastinoscopeEWY · Traditional | Aegis Surgical, Ltd. | 01/09/2015SE |
| K971166 | Optical Mediastinoscope with Plug-In Connection/Ocular EyepieceEWY · Traditional | Richard Wolf Medical Instruments Corp. | 08/27/1997SE |
| K954910 | Karl Storz Optical MediastinoscopeEWY · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/03/1995SE |
| K930215 | Flexible Trocar TubesEWY · Traditional | Olympus Corp. | 03/16/1993SE |
| K913829 | Olympus Flexible Tip ThoracoscopeEWY · Traditional | Olympus Corp. | 11/22/1991SE |
| K912362 | Oes Thoracoscope SystemEWY · Traditional | Olympus Corp. | 10/24/1991SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional | 05/15/2026SE |
| K240506 | KARL STORZ HoldersOCV · Traditional | 10/22/2024SE |
| K223885 | HOPKINS TelescopesHIH · Traditional | 09/14/2023SE |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
| K223520 | UNIDRIVE SIII SystemHIH · Traditional | 04/27/2023SE |
| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K221174 | Telepack +FET · Special | 05/13/2022SE |
Questions and answers
When was HD Mediastinoscope cleared by the FDA?
HD Mediastinoscope (K213194) received a 510(k) decision of Substantially Equivalent on June 23, 2022, 267 days after the submission was received.
What is the product code of K213194?
The FDA product code is EWY – Mediastinoscope, Surgical, a Class II (moderate risk) device regulated under 21 CFR 874.4720.