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FDA 510(k)

Sturdy Autoclave Super Microm

K-Number: K231489 · 2023-06-21

ApplicantSturdy Industrial Co., Ltd.
Decision Date2023-06-21
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sturdy Autoclave Super Microm is the device name listed in this FDA 510(k) record. The listed applicant is Sturdy Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K231489. 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 Sturdy Autoclave Super Microm?

Sturdy Autoclave Super Microm is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Sturdy Industrial Co., Ltd.. The 510(k) number is K231489.

When did Sturdy Autoclave Super Microm receive FDA 510(k) clearance?

Sturdy Autoclave Super Microm received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231489.

Who is the listed applicant for Sturdy Autoclave Super Microm?

The FDA 510(k) record lists Sturdy Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sturdy Autoclave Super Microm?

The FDA product code for Sturdy Autoclave Super Microm is FLE.

Other records listing Sturdy Industrial Co., Ltd. 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.

K181993STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)

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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