Cleared Special

K983017 - MODIFICATION TO SYSTEM 83 PLUS

K983017 is an FDA 510(k) clearance for MODIFICATION TO SYSTEM 83 PLUS, manufactured by Custom Ultrasonics. The device is a Class 2 General Hospital device with product code NVE cleared through the Special 510(k) pathway after a 25-day FDA review.

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

FDA 510(k) Submission Details - K983017

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

NVE Device Classification - Class 2, Special Controls

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 9
Devices cleared under the same product code (NVE) and FDA review panel - the closest regulatory comparables to K983017.
RAS 12 Rack, RAS 12 Long Rack
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K861821 · Keymed, Inc. · Feb 1987
AUTOMATIC ENDOSCOPE
K832458 · American Endoscopy, Inc. · Oct 1983