510(k) K231489
K231489 is an FDA 510(k) premarket notification submitted by Sturdy Industrial Co., Ltd. for the device "Sturdy Autoclave Super Microm". The FDA issued a decision of Substantially Equivalent on June 21, 2023. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Sturdy Industrial Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2023
- Date Received
- May 23, 2023
- Clearance Type
- Special
- 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