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510(k) K230339

EsoCheck Cell Collection Device by Lucid Diagnostics, Inc. — Product Code EOX

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 24, 2023
Date Received
February 7, 2023
Clearance Type
Special
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 Lucid Diagnostics, Inc.

  • K222366 — EsoCheck Cell Collection Device (October 26, 2022)
  • K210137 — EsoCheck Cell Collection Device (February 18, 2021)
  • K183262 — EsoCheck CCD Cell Collection Device (June 21, 2019)

Other clearances for product code EOX

  • K233142 — EndoSign® Cell collection device (ES-CYT-102) (January 19, 2024)
  • 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)
  • K181020 — Cytosponge Cell Collection Device (August 16, 2018)