Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Acu-sInQ Complete Endoscope Cleaning Aid System

K-Number: K181865 · 2018-12-14

ApplicantSTERIS Corporation
Decision Date2018-12-14
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Acu-sInQ Complete Endoscope Cleaning Aid System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K181865. 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 Acu-sInQ Complete Endoscope Cleaning Aid System?

Acu-sInQ Complete Endoscope Cleaning Aid System is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is STERIS Corporation. The 510(k) number is K181865.

When did Acu-sInQ Complete Endoscope Cleaning Aid System receive FDA 510(k) clearance?

Acu-sInQ Complete Endoscope Cleaning Aid System received FDA 510(k) clearance on 2018-12-14, under 510(k) number K181865.

Who is the listed applicant for Acu-sInQ Complete Endoscope Cleaning Aid System?

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

What is the FDA product code for Acu-sInQ Complete Endoscope Cleaning Aid System?

The FDA product code for Acu-sInQ Complete Endoscope Cleaning Aid System is FEB.

Other records listing STERIS Corporation 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.

K261055AMSCO 700 Steam SterilizerK260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K252680Celerity™ 20 HP Biological IndicatorK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

View all 139 devices →

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.

↑