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510(k) K233142

EndoSign® Cell collection device (ES-CYT-102) by Cyted Limited — Product Code EOX

K233142 is an FDA 510(k) premarket notification submitted by Cyted Limited for the device "EndoSign® Cell collection device (ES-CYT-102)". The FDA issued a decision of Substantially Equivalent on January 19, 2024. The device falls under product code EOX (Esophagoscope (Flexible Or Rigid)), a Class II device regulated under 21 CFR 874.4710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2024
Date Received
September 27, 2023
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 for product code EOX

  • 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)
  • K181020 — Cytosponge Cell Collection Device (August 16, 2018)

FDA data resources