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510(k) K151345

BioGuard Air/Water Valve, BioGuard Suction Valve by United States Endoscopy Group, Inc. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2015
Date Received
May 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by United States Endoscopy Group, Inc.

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  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K192059 — Bio Guard Air/Water & Suction Valves (September 17, 2019)
  • K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIF (August 1, 2019)
  • K182909 — Roth Net Retriever Product Line (November 21, 2018)
  • K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - (September 21, 2018)
  • K173650 — AquaShield System CO2- Fujifilm (January 5, 2018)
  • K172805 — gi-4000 Electrosurgical Generator (October 23, 2017)
  • K163495 — AdvanCE capsule endoscope delivery device (March 10, 2017)
  • K163492 — Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex (January 6, 2017)

Other clearances for product code ODC

  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si (March 22, 2024)