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510(k) K170757

Aegis Transit System by Boston-Biomedical Associates — Product Code EWY

K170757 is an FDA 510(k) premarket notification submitted by Boston-Biomedical Associates for the device "Aegis Transit System". The FDA issued a decision of Substantially Equivalent on July 14, 2017. The device falls under product code EWY (Mediastinoscope, Surgical), a Class II device regulated under 21 CFR 874.4720.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2017
Date Received
March 13, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mediastinoscope, Surgical
Device Class
Class II
Regulation Number
874.4720
Review Panel
EN
Submission Type

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 clearances for product code EWY

  • K260003 — KARL STORZ Mediastinoscopes and Instruments (March 2, 2026)
  • K213194 — HD Mediastinoscope (June 23, 2022)
  • K202272 — HD Mediastinoscope (May 11, 2021)
  • K160171 — Illuminated Mediastinal Access Port (February 26, 2016)
  • K141622 — ILLUMINATED MEDIASTINOSCOPE (January 9, 2015)
  • K971166 — OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE (August 27, 1997)
  • K954910 — KARL STORZ OPTICAL MEDIASTINOSCOPE (November 3, 1995)
  • K930215 — FLEXIBLE TROCAR TUBES (March 16, 1993)
  • K913829 — OLYMPUS FLEXIBLE TIP THORACOSCOPE (November 22, 1991)
  • K912362 — OES THORACOSCOPE SYSTEM (October 24, 1991)

FDA data resources