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510(k) K213483

SnapLoc Wire Lock by Wilson Cook Medical — Product Code ODC

K213483 is an FDA 510(k) premarket notification submitted by Wilson Cook Medical for the device "SnapLoc Wire Lock". The FDA issued a decision of Substantially Equivalent on Apr 26, 2022. 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
Apr 26, 2022
Date Received
Oct 29, 2021
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.

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  • 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