510(k) K231260
K231260 is an FDA 510(k) premarket notification submitted by Suzhou AcuVu Medical Technology Co., Ltd. for the device "HTx Disposable Hysteroscope System". The FDA issued a decision of Substantially Equivalent on March 5, 2024. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Suzhou AcuVu Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2024
- Date Received
- May 1, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type