Optical Mediastinoscope with Plug-In Connection/Ocular Eyepiece
FDA 510(k) K971166 · Richard Wolf Medical Instruments Corp.
510(k) numberK971166
Submission
- Device name
- Optical Mediastinoscope with Plug-In Connection/Ocular Eyepiece
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- March 31, 1997
- Decision date
- August 27, 1997
- 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).
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| K260003 | KARL STORZ Mediastinoscopes and InstrumentsEWY · Traditional | Karl Storz SE & CO. KG | 03/02/2026SE |
| K213194 | HD MediastinoscopeEWY · Traditional | Karl Storz Endoscopy America, Inc. | 06/23/2022SE |
| 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 |
| 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 |
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Questions and answers
When was Optical Mediastinoscope with Plug-In Connection/Ocular Eyepiece cleared by the FDA?
Optical Mediastinoscope with Plug-In Connection/Ocular Eyepiece (K971166) received a 510(k) decision of Substantially Equivalent on August 27, 1997, 149 days after the submission was received.
What is the product code of K971166?
The FDA product code is EWY – Mediastinoscope, Surgical, a Class II (moderate risk) device regulated under 21 CFR 874.4720.