510(k) K954910

KARL STORZ OPTICAL MEDIASTINOSCOPE by KARL STORZ Endoscopy-America, Inc. — Product Code EWY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 3, 1995
Date Received: October 25, 1995
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 by KARL STORZ Endoscopy-America, Inc.

K223923 — HOPKINS Telescopes (March 30, 2023)
K202957 — Flexible Video Cysto-Urethroscope (C-view) (October 29, 2020)
K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver (October 22, 2020)
K201135 — Image1 S CCU, Image1 S 4U Camera Head (September 1, 2020)
K200740 — HD Video Rhino Laryngoscope (August 11, 2020)
K191357 — Flexible HD Cysto-Urethroscope System (September 18, 2019)
K182723 — Flexible HD Cysto-Urethroscope System (April 23, 2019)
K182186 — CMOS Video-Rhino-Laryngoscope System (March 22, 2019)
K183264 — Flex-THOR scope (January 18, 2019)
K182696 — Telepack X LED (November 20, 2018)

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)
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)
K930215 — FLEXIBLE TROCAR TUBES (March 16, 1993)
K913829 — OLYMPUS FLEXIBLE TIP THORACOSCOPE (November 22, 1991)
K912362 — OES THORACOSCOPE SYSTEM (October 24, 1991)