Cleared Traditional

K241168 - System 83 Revolve Endoscope Washer/Disi...

K241168 is an FDA 510(k) clearance for System 83 Revolve Endoscope Washer/Disi..., manufactured by Wassenburg Medical, Inc.. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K241168 · Wassenburg Medical, Inc. · General Hospital
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Dec 2024
Decision
237d
Days
Class 2
Risk

K241168 is an FDA 510(k) clearance for the System 83 Revolve Endoscope Washer/Disinfector. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Wassenburg Medical, Inc. (Ivyland, US). The FDA issued a Cleared decision on December 19, 2024 after a review of 237 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Wassenburg Medical, Inc. devices

FDA 510(k) Submission Details - K241168

510(k) Number K241168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 129d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEB Device Classification - Class 2, Special Controls

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FEB Accessories, Cleaning, For Endoscope

All 30
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K241168.
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
K243433 · STERIS Corporation · Dec 2024
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
K230930 · STERIS Corporation · Jun 2023
SCOPE BUDDY PLUS Endoscope Flushing Aid
K213833 · Medivators, Inc. · Jan 2022
Endoscope Reprocessor OER-Elite
K201920 · Olympus Medical Systems Corp. · Sep 2020
System 83 Plus Washer/Disinfector
K173590 · Custom Ultrasonics, Inc. · Mar 2020
ENDOSCOPE REPROCESSOR OER-Elite
K190969 · Olympus Medical Systems Corp. · Jul 2019