510(k) K202445
K202445 is an FDA 510(k) premarket notification submitted by Hysterovue, Inc. for the device "Hystero-V Hysteroscope". The FDA issued a decision of Substantially Equivalent on Nov 23, 2021. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 23, 2021
- Date Received
- Aug 26, 2020
- 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)