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510(k) K051972

KARL STORZ TRANS-NASAL ESOPHAGOSCOPE by KARL STORZ Endoscopy-America, Inc. — Product Code EOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2005
Date Received
July 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Esophagoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4710
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 EOX

  • K233142 — EndoSign® Cell collection device (ES-CYT-102) (January 19, 2024)
  • K230339 — EsoCheck Cell Collection Device (February 24, 2023)
  • K223072 — PENTAX Medical Video Esophagoscope EE17-J10 (December 2, 2022)
  • K222366 — EsoCheck Cell Collection Device (October 26, 2022)
  • K203450 — EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) (May 4, 2021)
  • K210137 — EsoCheck Cell Collection Device (February 18, 2021)
  • K192523 — CMOS Video Esophagoscope SSU (January 24, 2020)
  • K183262 — EsoCheck CCD Cell Collection Device (June 21, 2019)
  • K182159 — Strome-Blitzer Cytology Balloon (June 13, 2019)
  • K181292 — PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor (November 15, 2018)