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510(k) K844691

ENDOSCOPIC ASPIRATION CATHETER SET by Jayco Pharmaceuticals — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1985
Date Received
December 3, 1984
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 Jayco Pharmaceuticals

  • K844689 — ENDOSCOPIC MANUAL AIR INSUFFLATOR (January 2, 1985)
  • K844690 — ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT (January 2, 1985)
  • K842009 — ABDOMINAL PARACENTESIS TRAY (October 23, 1984)
  • K842001 — LIVER BIOPSY TRAY (October 15, 1984)
  • K841258 — FOREIGN BODY PROTECTOR (July 9, 1984)
  • K840800 — POLYP-SAVER SLEVE (March 23, 1984)
  • K830781 — ENDO-GUARD (March 31, 1983)
  • K810875 — FECAL STAINING KIT (May 1, 1981)

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)