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FDA 510(k)

STERRAD 50 & STERRAD 100S STERILIZERS

K-Number: K023290 · 2003-04-03

ApplicantAdvanced Sterilization Products
Decision Date2003-04-03
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD 50 & STERRAD 100S STERILIZERS 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 2003-04-03 under 510(k) number K023290. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERRAD 50 & STERRAD 100S STERILIZERS?

STERRAD 50 & STERRAD 100S STERILIZERS is a medical device that received FDA 510(k) clearance on 2003-04-03. The listed applicant is Advanced Sterilization Products. The 510(k) number is K023290.

When did STERRAD 50 & STERRAD 100S STERILIZERS receive FDA 510(k) clearance?

STERRAD 50 & STERRAD 100S STERILIZERS received FDA 510(k) clearance on 2003-04-03, under 510(k) number K023290.

Who is the listed applicant for STERRAD 50 & STERRAD 100S STERILIZERS?

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 STERRAD 50 & STERRAD 100S STERILIZERS?

The FDA product code for STERRAD 50 & STERRAD 100S STERILIZERS is FLF.

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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: FLF)

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.

K192978EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.K090636TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.K051595TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.K020875TSO3 OZONE STERILIZER, MODEL 125LTechnologies of Sterilization With Oxone, Tso3, Inc.K014013H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEMH & W Technology, LLC

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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