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510(k) K993778

HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 by Northgate Technologies, Inc. — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2000
Date Received
November 8, 1999
Clearance Type
Special
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.

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  • K120151 — NEBULAE I (August 17, 2012)
  • K041560 — FLO-ASSISTANT (September 28, 2004)
  • K033614 — MISTIC HUMIDIFICATION SYSTEM 850-00/0 (July 29, 2004)
  • K022052 — 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 (January 24, 2003)
  • K010053 — HUMI-FLOW, MODEL 6-850-00/ 01/02 (October 23, 2001)
  • K011928 — HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 (August 10, 2001)
  • K001325 — FLO ASSISTANT, MODEL 4-250-00 (August 18, 2000)

Other clearances for product code OCX

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  • 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)