Aegis Transit System
FDA 510(k) K170757 · Boston-Biomedical Associates
510(k) numberK170757
Submission
- Device name
- Aegis Transit System
- Applicant
- Boston-Biomedical Associates
Malborough, MA, US - Received
- March 13, 2017
- Decision date
- July 14, 2017
- 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 |
| K213194 | HD MediastinoscopeEWY · Traditional | Karl Storz Endoscopy America, Inc. | 06/23/2022SE |
| K202272 | HD MediastinoscopeEWY · Traditional | Karl Storz Endoscopy America, Inc. | 05/11/2021SE |
| 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 |
Questions and answers
When was Aegis Transit System cleared by the FDA?
Aegis Transit System (K170757) received a 510(k) decision of Substantially Equivalent on July 14, 2017, 123 days after the submission was received.
What is the product code of K170757?
The FDA product code is EWY – Mediastinoscope, Surgical, a Class II (moderate risk) device regulated under 21 CFR 874.4720.