510(k) K160171
- Device
- Illuminated Mediastinal Access Port
- Applicant
- Aegis Surgical Ltd
- 510(k) number
- K160171
- Product code
- EWY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-02-26
- Date received
- 2016-01-27
- Regulation
- 874.4720
- Classification name
- Mediastinoscope, Surgical
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- William Starling
- Address
- 4020 Stirrup Creek Dr. Suite 115 Durham NC US 27703 27703
FDA Registration Numbers#
- 3013247477
- 3003761012
- 9611616
- 3014342096
- 8010257
- 2020550
- 3011137372
- 3010707607
- 3012322232
- 3010202439
- 3010041511
- 3011050570
- 9610617
- 8010935
- 9611503
- 9610773
- 9611102
- 1047843
- 3006546082
Source Documents#
Other 510(k) Records For Product Code EWY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | 2026-03-02 |
| K213194 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2022-06-23 |
| K202272 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2021-05-11 |
| K170757 | Aegis Transit System | Boston-Biomedical Associates | 2017-07-14 |
| K141622 | ILLUMINATED MEDIASTINOSCOPE | Aegis Surgical, Ltd. | 2015-01-09 |
| K971166 | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE | Richard Wolf Medical Instruments Corp. | 1997-08-27 |
| K954910 | KARL STORZ OPTICAL MEDIASTINOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1995-11-03 |
| K930215 | FLEXIBLE TROCAR TUBES | Olympus Corp. | 1993-03-16 |
| K913829 | OLYMPUS FLEXIBLE TIP THORACOSCOPE | Olympus Corp. | 1991-11-22 |
| K912362 | OES THORACOSCOPE SYSTEM | Olympus Corp. | 1991-10-24 |
Legacy Summary#
summary
FDA Review#
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