Cleared Special

MODIFICATION TO SYSTEM 83 PLUS (K983017) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K983017 · Custom Ultrasonics · General Hospital
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Sep 1998
Decision
25d
Days
Class 2
Risk

K983017 is an FDA 510(k) clearance for the MODIFICATION TO SYSTEM 83 PLUS. Classified as Washer, Cleaner, Automated, Endoscope (product code NVE), Class II - Special Controls.

Submitted by Custom Ultrasonics (Ivyland, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 25 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.

View all Custom Ultrasonics devices

Submission Details

510(k) Number K983017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1998
Decision Date September 22, 1998
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NVE Washer, Cleaner, Automated, Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition This Automated Device Is Intended To Be Used To Clean Endoscopes. Endoscopes That Are Intended To Be Cleaned By The Automated Cleaner System Should Have Been Pre-cleaned And Tested For Leaks And Lumen Obstructions According To The Instrument Manufacturer's Instructions And Current Professional Practices Prior To Processing In The System. The System Includes A Chemical Dispensing System That Meters Out A Predetermined Volume Of Detergent During The Appropriate Cleaning Cycle. 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). The Instrument Is Placed In A Tray With Each Lumen End Positioned In Opposite Sides Of The Tray To Allow Enough Detergent And Rinsing Water Pass Through The Lumens Of The Endoscopes.
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 - NVE Washer, Cleaner, Automated, Endoscope

All 11
Devices cleared under the same product code (NVE) and FDA review panel - the closest regulatory comparables to K983017.
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
K222849 · Steris · Sep 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
K222543 · Steris · Aug 2022
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
K203199 · STERIS Corporation · Dec 2020
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
K200577 · STERIS Corporation · Apr 2020
RAS 12 Rack, RAS 12 Long Rack
K190081 · STERIS Corporation · Aug 2019