510(k) K190797
K190797 is an FDA 510(k) premarket notification submitted by Reed Medical (Zhejiang) Co., Ltd. for the device "Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)". The FDA issued a decision of Substantially Equivalent on Nov 18, 2019. 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 18, 2019
- Date Received
- Mar 28, 2019
- 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)