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510(k) K160171

Illuminated Mediastinal Access Port by Aegis Surgical, Ltd. — Product Code EWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2016
Date Received
January 27, 2016
Clearance Type
Special
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 by Aegis Surgical, Ltd.

  • K141622 — ILLUMINATED MEDIASTINOSCOPE (January 9, 2015)

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)
  • K170757 — Aegis Transit System (July 14, 2017)
  • 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)