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FDA 510(k)

EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR

K-Number: K082392 · 2008-11-13

ApplicantAdvanced Sterilization Products
Decision Date2008-11-13
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2008-11-13 under 510(k) number K082392. 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 EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR?

EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR is a medical device that received FDA 510(k) clearance on 2008-11-13. The listed applicant is Advanced Sterilization Products. The 510(k) number is K082392.

When did EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR receive FDA 510(k) clearance?

EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR received FDA 510(k) clearance on 2008-11-13, under 510(k) number K082392.

Who is the listed applicant for EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR?

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

What is the FDA product code for EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR?

The FDA product code for EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR is FEB.

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Other records listing Advanced Sterilization Products 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.

K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical IndicatorK162007STERRAD NX SterilizerK160818STERRAD® NX Sterilizer with ALLClear™ TechnologyK160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyK151725STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

View all 49 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.

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