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510(k) K203630

BioGuard Air/Water and Suction Valves by Steris Corporations — Product Code ODC

K203630 is an FDA 510(k) premarket notification submitted by Steris Corporations for the device "BioGuard Air/Water and Suction Valves". The FDA issued a decision of Substantially Equivalent on January 8, 2021. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Steris Corporations has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2021
Date Received
December 11, 2020
Clearance Type
Special
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 Steris Corporations

  • K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem (March 22, 2019)
  • K183295 — Celerity HP Chemical Indicator (CI) (January 4, 2019)
  • K183300 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator (January 3, 2019)
  • K182931 — VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Tes (November 20, 2018)
  • K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System (April 4, 2018)
  • K172748 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator (February 9, 2018)

Other clearances for product code ODC

  • K252933 — DYNE PORT (June 12, 2026)
  • 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)

FDA data resources