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FDA 510(k)

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

K-Number: K151725 · 2016-01-13

ApplicantAdvanced Sterilization Products
Decision Date2016-01-13
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer 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 2016-01-13 under 510(k) number K151725. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERRAD NX Sterilizer, STERRAD 100NX Sterilizer?

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Advanced Sterilization Products. The 510(k) number is K151725.

When did STERRAD NX Sterilizer, STERRAD 100NX Sterilizer receive FDA 510(k) clearance?

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151725.

Who is the listed applicant for STERRAD NX Sterilizer, STERRAD 100NX Sterilizer?

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 NX Sterilizer, STERRAD 100NX Sterilizer?

The FDA product code for STERRAD NX Sterilizer, STERRAD 100NX Sterilizer is MLR.

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.

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)K220404STERRAD NX with ALLClear TechnologyK212174STERRAD 100NX Sterilizer with ALLClear Technology

View all 11 devices →

Related Devices (Code: MLR)

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.

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization ProductsK233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris

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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