Home / 510(k) Clearances / K833331

510(k) K833331

ASPIRATION & IRRIGATION CATHETER by Microvasive — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
September 27, 1983
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 Microvasive

  • K872771 — LOW PROFILE GASTROSTOMY (October 9, 1987)
  • K870705 — THERMAL COAGULATOR (April 17, 1987)
  • K861309 — JEJUNAL FEEDING TUBE (December 16, 1986)
  • K861323 — REPLACEMENT GASTROSTOMY TUBE (December 16, 1986)
  • K860589 — INFLATOR/DEFLATOR PISTON SYRINGE (April 7, 1986)
  • K860366 — CHALLENGER HOT BIOPSY FORCEPS (April 7, 1986)
  • K854238 — NEEDLE W/STYLET FOR IMPLANTATION (November 13, 1985)
  • K854063 — MICROVASIVE SILICONE SPRAY (October 25, 1985)
  • K851652 — PAPILLOTOME (June 24, 1985)
  • K850393 — FLEXIBLE FIBEROPTIC ENDOSCOPE (June 4, 1985)

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)