Cassette Autoclave (ACA5)
K-Number: K250164 · 2025-08-14
Decision Date2025-08-14
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Cassette Autoclave (ACA5) is a medical device manufactured by Guangzhou Ajax Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-08-14 under approval number K250164. 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 Cassette Autoclave (ACA5)?
Cassette Autoclave (ACA5) is a medical device that received FDA 510(k) clearance on 2025-08-14. It is manufactured by Guangzhou Ajax Medical Equipment Co., Ltd.. The 510(k) number is K250164.
When was Cassette Autoclave (ACA5) approved by the FDA?
Cassette Autoclave (ACA5) received FDA 510(k) clearance on 2025-08-14, under approval number K250164.
What company makes Cassette Autoclave (ACA5)?
Cassette Autoclave (ACA5) is manufactured by Guangzhou Ajax Medical Equipment Co., Ltd..
What is the FDA product code for Cassette Autoclave (ACA5)?
The FDA product code for Cassette Autoclave (ACA5) is 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.