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510(k) K120702

E.G. SCAN II ESPHAGOSCOPE SYSTEM by Intromedic Co., Ltd. — Product Code EOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2012
Date Received
March 8, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Intromedic Co., Ltd.

  • K180732 — MiroCam Capsule Endoscope System (November 8, 2018)
  • K170438 — MiroCam Capsule Endoscope System (January 30, 2018)
  • K143663 — MiroCam Capsule Endoscope System (March 17, 2015)
  • K134005 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (July 9, 2014)
  • K140751 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (June 30, 2014)
  • K131131 — E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM (June 21, 2013)
  • K123428 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (May 20, 2013)
  • K111450 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (May 18, 2012)
  • K111030 — E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM (October 21, 2011)

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)