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)

STERRAD NX Sterilizer

K-Number: K162007 · 2017-02-16

Decision Date2017-02-16
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD NX 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 2017-02-16 under 510(k) number K162007. 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 NX Sterilizer is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Advanced Sterilization Products. The 510(k) number is K162007.

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

STERRAD NX Sterilizer received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162007.

Who is the listed applicant for STERRAD NX 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?

The FDA product code for STERRAD NX 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.

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.

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.