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510(k) K220884

Disposable Endoscope Valve Sets by Sml Med-Tech Solutions Limited — Product Code ODC

K220884 is an FDA 510(k) premarket notification submitted by Sml Med-Tech Solutions Limited for the device "Disposable Endoscope Valve Sets". The FDA issued a decision of Substantially Equivalent on Jan 17, 2023. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 17, 2023
Date Received
Mar 28, 2022
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
510(k)

To give the endoscope channel additional or improved functionality.

Other clearances for product code ODC

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  • K252910 — Orca Air/Water and Suction Valves (Oct 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (Jul 16, 2025)
  • K250732 — Disposable Endoscopy Valve Set (Jun 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (Mar 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (Feb 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323… (Nov 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (Oct 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (Oct 1, 2024)

FDA data resources