510(k) K213194

HD Mediastinoscope by Karl Storz Endoscopy America, Inc. — Product Code EWY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 23, 2022
Date Received: September 29, 2021
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.

K240506 — KARL STORZ Holders (October 22, 2024)
K223885 — HOPKINS Telescopes (September 14, 2023)
K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (3 (June 23, 2023)
K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 2023)
K221004 — HOPKINS Telescopes (December 20, 2022)
K222504 — H1 (November 10, 2022)
K221174 — Telepack + (May 13, 2022)
K212458 — Flexible Video-Uretero-Renoscope SSU System (January 20, 2022)
K212656 — Flexible Intubation Video Endoscope Sterile (FIVE-S) (December 29, 2021)
K212695 — KARL STORZ ICG Imaging System (November 15, 2021)

Other clearances for product code EWY

K260003 — KARL STORZ Mediastinoscopes and Instruments (March 2, 2026)
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)
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)