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FDA 510(k)

STERRADD STERILIZATION SYSTEM

K-Number: K954142 · 1997-06-06

ApplicantAdvanced Sterilization Products
Decision Date1997-06-06
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRADD STERILIZATION SYSTEM 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 1997-06-06 under 510(k) number K954142. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERRADD STERILIZATION SYSTEM?

STERRADD STERILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Advanced Sterilization Products. The 510(k) number is K954142.

When did STERRADD STERILIZATION SYSTEM receive FDA 510(k) clearance?

STERRADD STERILIZATION SYSTEM received FDA 510(k) clearance on 1997-06-06, under 510(k) number K954142.

Who is the listed applicant for STERRADD STERILIZATION SYSTEM?

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 STERRADD STERILIZATION SYSTEM?

The FDA product code for STERRADD STERILIZATION SYSTEM is FLE.

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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: FLE)

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 SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

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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