Cleared Traditional

System 83 Revolve Endoscope Washer/Disinfector

K241168 · Wassenburg Medical, Inc. · General Hospital

Dec 2024

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K241168 is an FDA 510(k) clearance for the System 83 Revolve Endoscope Washer/Disinfector, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Wassenburg Medical, Inc. (Ivyland, US). The FDA issued a Cleared decision on December 19, 2024, 237 days after receiving the submission on April 26, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K241168 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2024
Decision Date	December 19, 2024
Days to Decision	237 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FEB — Accessories, Cleaning, For Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).