SYSTEM 83 PLUS— 510(k) K122172

Name: FDA 510(k) clearance K122172
Creator: U.S. Food and Drug Administration
Published: 2013-01-25

Substantially Equivalent

Custom Ultrasonics

FDA 510(k) clearance K122172 for SYSTEM 83 PLUS, Substantially Equivalent on 2013-01-25. Applicant: Custom Ultrasonics. Device class: 2.

Clearance details

Applicant: Custom Ultrasonics
Product code: Code FEB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2012-07-23
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Ivyland, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FEB

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More clearances from Custom Ultrasonics

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K061430 — SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR2007-01-12
K983017 — MODIFICATION TO SYSTEM 83 PLUS1998-09-22
K842754 — CUSTOM ULTRASONICS-SYS 80, 81-24, 83-21984-11-28

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K122172

K-number listed on FDA's recall record

Z-0426-2014 — Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.Class II·Terminated·Custom Ultrasonics, Inc.·20130312

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122172.

Data sourced from openFDA. This site is unofficial and independent of the FDA.