Cleared Special

K082392 - EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR

K082392 is an FDA 510(k) clearance for EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code FEB cleared through the Special 510(k) pathway after a 86-day FDA review.

K082392 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
86d
Days
Class 2
Risk

K082392 is an FDA 510(k) clearance for the EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on November 13, 2008 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082392

510(k) Number K082392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2008
Decision Date November 13, 2008
Days to Decision 86 days
Submission Type Special
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
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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 57
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K082392.
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
K092387 · Minntech Corp. · Apr 2010
ENDOSCOPE REPROCESSOR OER-PRO
K093106 · Olympus Medical Systems Corporation · Feb 2010
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
K082988 · Medivators Reprocessing Systems · Feb 2009
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
K063876 · Medivators Reprocessing Systems · Jun 2007
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
K061430 · Custom Ultrasonics · Jan 2007
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K061899 · Advanced Sterilization Products · Oct 2006
K082392 · EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
Download PDF FDA Summary Advanced Sterilizatio…