Home / 510(k) Clearances / K142068

510(k) K142068

BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE by Medovations, Inc. — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2015
Date Received
July 30, 2014
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 Medovations, Inc.

  • K002363 — MEDOVATIONS ESOPHAGEAL DILATOR (November 1, 2000)
  • K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (February 2, 1998)
  • K924646 — OVER THE GUIDEWIRE DILATATION SYSTEM (December 5, 1994)
  • K913678 — TROCAR CATHETER (December 16, 1991)
  • K905478 — YANKAUER SUCTION DEVICE (December 19, 1990)
  • K874309 — URETHAL CATHETER (December 7, 1987)
  • K864963 — STOMACH EVACULATOR - EWALD STYLE (October 14, 1987)
  • K864962 — OBERTO MOUTH PROP (February 19, 1987)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)
  • K854616 — ENTERAL FEEDING BAG (January 23, 1986)

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)