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510(k) K903834

N. M. BEALE COMPANY VU-THRU WATER BOTTLE by N.M. Beale Co., Inc. — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1990
Date Received
August 21, 1990
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 N.M. Beale Co., Inc.

  • K093584 — EZ-MISTER (March 4, 2011)
  • K093329 — SCOPE INTRODUCER MODEL 7400 (February 16, 2010)
  • K071579 — PEF TUBE (November 20, 2007)
  • K992178 — BALLOON FOR ULTRASONIC ENDOSCOPES (May 12, 2000)

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)