Cleared Traditional

K170757 - Aegis Transit System

K170757 is an FDA 510(k) clearance for Aegis Transit System, manufactured by Boston-Biomedical Associates. The device is a Class 2 Ear, Nose, Throat device with product code EWY cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K170757 · Boston-Biomedical Associates · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
123d
Days
Class 2
Risk

K170757 is an FDA 510(k) clearance for the Aegis Transit System. Classified as Mediastinoscope, Surgical (product code EWY), Class II - Special Controls.

Submitted by Boston-Biomedical Associates (Malborough, US). The FDA issued a Cleared decision on July 14, 2017 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4720 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston-Biomedical Associates devices

FDA 510(k) Submission Details - K170757

510(k) Number K170757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2017
Decision Date July 14, 2017
Days to Decision 123 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 89d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWY Device Classification - Class 2, Special Controls

Product Code EWY Mediastinoscope, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4720
Definition 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWY Mediastinoscope, Surgical

All 8
Devices cleared under the same product code (EWY) and FDA review panel - the closest regulatory comparables to K170757.
KARL STORZ Mediastinoscopes and Instruments
K260003 · Karl Storz SE & CO. KG · Mar 2026
HD Mediastinoscope
K213194 · KARL STORZ Endoscopy-America, Inc. · Jun 2022
HD Mediastinoscope
K202272 · KARL STORZ Endoscopy-America, Inc. · May 2021
OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
K971166 · Richard Wolf Medical Instruments Corp. · Aug 1997
KARL STORZ OPTICAL MEDIASTINOSCOPE
K954910 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
FLEXIBLE TROCAR TUBES
K930215 · Olympus Corp. · Mar 1993