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FDA 510(k)

SYSTEM 83 PLUS

K-Number: K122172 · 2013-01-25

ApplicantCustom Ultrasonics
Decision Date2013-01-25
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYSTEM 83 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Custom Ultrasonics. It received FDA 510(k) clearance on 2013-01-25 under 510(k) number K122172. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 83 PLUS?

SYSTEM 83 PLUS is a medical device that received FDA 510(k) clearance on 2013-01-25. The listed applicant is Custom Ultrasonics. The 510(k) number is K122172.

When did SYSTEM 83 PLUS receive FDA 510(k) clearance?

SYSTEM 83 PLUS received FDA 510(k) clearance on 2013-01-25, under 510(k) number K122172.

Who is the listed applicant for SYSTEM 83 PLUS?

The FDA 510(k) record lists Custom Ultrasonics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM 83 PLUS?

The FDA product code for SYSTEM 83 PLUS is FEB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Custom Ultrasonics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061430SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTORK983017MODIFICATION TO SYSTEM 83 PLUSK842754CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2

Related Devices (Code: FEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS CorporationK230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS CorporationK213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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