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FDA 510(k)

SteroScope® Sterilization Technology System

K-Number: K233762 · 2024-06-27

ApplicantIdeate Medical, Inc.
Decision Date2024-06-27
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteroScope® Sterilization Technology System is the device name listed in this FDA 510(k) record. The listed applicant is Ideate Medical, Inc.. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K233762. 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 SteroScope® Sterilization Technology System?

SteroScope® Sterilization Technology System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Ideate Medical, Inc.. The 510(k) number is K233762.

When did SteroScope® Sterilization Technology System receive FDA 510(k) clearance?

SteroScope® Sterilization Technology System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K233762.

Who is the listed applicant for SteroScope® Sterilization Technology System?

The FDA 510(k) record lists Ideate Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SteroScope® Sterilization Technology System?

The FDA product code for SteroScope® Sterilization Technology System is MLR.

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 ProductsK233065V-PRO maX 2 Low Temperature Sterilization SystemSterisK223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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