510(k) K211227
K211227 is an FDA 510(k) premarket notification submitted by Acuvu, Inc. for the device "HTx Disposable Hysteroscope System". The FDA issued a decision of Substantially Equivalent on Sep 15, 2021. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Acuvu, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 15, 2021
- Date Received
- Apr 23, 2021
- 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
- 510(k)