510(k) K250164
K250164 is an FDA 510(k) premarket notification submitted by Guangzhou Ajax Medical Equipment Co., Ltd. for the device "Cassette Autoclave (ACA5)". The FDA issued a decision of Substantially Equivalent on August 14, 2025. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Guangzhou Ajax Medical Equipment Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2025
- Date Received
- January 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type