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510(k) K202616

ClearCap Distal Attachment by Finemedix Co., Ltd. — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2021
Date Received
September 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Irrigation/Suction System
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

Other clearances by Finemedix Co., Ltd.

  • K250994 — ClearTip FNA and FNB Types (August 21, 2025)
  • K242857 — ClearHemograsper (May 21, 2025)
  • K242134 — ClearCap Distal Attachment (August 20, 2024)
  • K231267 — ClearTip (June 30, 2023)
  • K200217 — ClearEndoclip (October 5, 2020)
  • K183021 — ClearEndoclip (June 28, 2019)
  • K183289 — ClearGrasp Snare (March 6, 2019)
  • K181690 — Clear-Jet Injection Catheter (December 21, 2018)
  • K180363 — Clear-Tip EUS-FNA (November 1, 2018)

Other clearances for product code OCX

  • K251986 — AUXILIARY WATER TUBE MAJ-855 (September 26, 2025)
  • K251997 — Single-Use Biopsy Valve (MAJ-1555) (September 25, 2025)
  • K242586 — ArgoCap (200.52) (May 22, 2025)
  • K241704 — Endoscopic Water Pump (March 20, 2025)
  • K242357 — Water Container (MAJ-901); Water Container (MAJ-902) (October 7, 2024)
  • K241874 — Aspiration Catheter (2189) (September 24, 2024)
  • K242134 — ClearCap Distal Attachment (August 20, 2024)
  • K233442 — troCarWash™ System (May 21, 2024)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)