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510(k) K202272

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2021
Date Received
August 11, 2020
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)
  • K213194 — HD Mediastinoscope (June 23, 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)

Other clearances for product code EWY

  • K260003 — KARL STORZ Mediastinoscopes and Instruments (March 2, 2026)
  • K213194 — HD Mediastinoscope (June 23, 2022)
  • 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)