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510(k) K875264

WASHING CATHETER by Endovations — Product Code OCX

K875264 is an FDA 510(k) premarket notification submitted by Endovations for the device "WASHING CATHETER". The FDA issued a decision of Substantially Equivalent on March 29, 1988. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Endovations has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1988
Date Received
December 22, 1987
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 Endovations

  • K955413 — ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER (February 8, 1996)
  • K942110 — INJECT-SNARE (October 13, 1994)
  • K944049 — OXYGEN MOUTHGUARD (October 11, 1994)
  • K934315 — ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME (February 28, 1994)
  • K913841 — 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH (October 8, 1991)
  • K913870 — 5MM MICROSCISSORS (September 16, 1991)
  • K911155 — OVAL CUP BIOPSY FORCEP (August 7, 1991)
  • K892218 — ENDO-SPONGE (May 31, 1989)
  • K883093 — TRANSENDOSCOPIC ASPIRATION NEEDLE (December 8, 1988)
  • K873360 — ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG (March 30, 1988)

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)

FDA data resources