Cleared Special

Defendo Single Use Cleaning Adapter for Olympus Endoscopes

K240352 · STERIS Corporation · Gastroenterology & Urology

Mar 2024

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K240352 is an FDA 510(k) clearance for the Defendo Single Use Cleaning Adapter for Olympus Endoscopes, a Endoscope Channel Accessory (Class II — Special Controls, product code ODC), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 6, 2024, 30 days after receiving the submission on February 5, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K240352 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2024
Decision Date	March 06, 2024
Days to Decision	30 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	ODC — Endoscope Channel Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Give The Endoscope Channel Additional Or Improved Functionality.