510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170757Substantially Equivalent

Aegis Transit System

Boston-Biomedical Associates, Malborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170757 is the FDA 510(k) clearance record for Aegis Transit System, a class II device, cleared for Boston-Biomedical Associates on under FDA product code EWY (Mediastinoscope, Surgical). FDA's definition for product code EWY reads: "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...". FDA records list one 510(k) clearance for Boston-Biomedical Associates. As of , FDA records show no recalls naming K170757.

Clearance record

Decision date
Received
(123 days to decision)
Product code
EWY Mediastinoscope, Surgical
Regulation
21 CFR 874.4720
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Boston-Biomedical Associates 100 Crowley Dr., Malborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EWY

Trailing 12 months
1 clearance under product code EWY in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EWY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260