EWY · Mediastinoscope, Surgical
Ear, Nose, Throat · 21 CFR 874.4720 · Class 2
Overview
| Product Code | EWY |
|---|---|
| Device Name | Mediastinoscope, Surgical |
| Regulation | 21 CFR 874.4720 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.
Classification Rationale
Class II.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | Mar 2, 2026 | SESE |
| K213194 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | Jun 23, 2022 | SESE |
| K202272 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | May 11, 2021 | SESE |
| K170757 | Aegis Transit System | Boston-Biomedical Associates | Jul 14, 2017 | SESE |
| K160171 | Illuminated Mediastinal Access Port | Aegis Surgical, Ltd. | Feb 26, 2016 | SESE |
| K141622 | ILLUMINATED MEDIASTINOSCOPE | Aegis Surgical, Ltd. | Jan 9, 2015 | SESE |
| K971166 | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE | Richard Wolf Medical Instruments Corp. | Aug 27, 1997 | SESE |
| K954910 | KARL STORZ OPTICAL MEDIASTINOSCOPE | KARL STORZ Endoscopy-America, Inc. | Nov 3, 1995 | SESE |
| K930215 | FLEXIBLE TROCAR TUBES | Olympus Corp. | Mar 16, 1993 | SESE |
| K913829 | OLYMPUS FLEXIBLE TIP THORACOSCOPE | Olympus Corp. | Nov 22, 1991 | SESE |
| K912362 | OES THORACOSCOPE SYSTEM | Olympus Corp. | Oct 24, 1991 | SESE |
Top Applicants
- Olympus Corp. — 3 clearances
- Karl Storz Endoscopy America, Inc. — 2 clearances
- Aegis Surgical, Ltd. — 2 clearances
- Richard Wolf Medical Instruments Corp. — 1 clearance
- Karl Storz SE & CO. KG — 1 clearance
