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FDA 510(k)

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

K-Number: K181993 · 2019-11-01

ApplicantSturdy Industrial Co., Ltd.
Decision Date2019-11-01
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a medical device manufactured by Sturdy Industrial Co., Ltd.. It received FDA 510(k) clearance on 2019-11-01 under approval number K181993. 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 (models SA-260MA and SA-260MA-R)?

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Sturdy Industrial Co., Ltd.. The 510(k) number is K181993.

When was STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) approved by the FDA?

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) received FDA 510(k) clearance on 2019-11-01, under approval number K181993.

What company makes STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)?

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is manufactured by Sturdy Industrial Co., Ltd..

What is the FDA product code for STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)?

The FDA product code for STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is FLE.

Other Devices by Sturdy Industrial Co., Ltd.

K231489Sturdy Autoclave Super Microm

Related Devices (Code: FLE)

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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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