510(k) K201970
K201970 is an FDA 510(k) premarket notification submitted by Schoelly Fiberoptic GmbH for the device "Schoelly Cystoscopes/Hysteroscopes and Accessories". The FDA issued a decision of Substantially Equivalent on October 8, 2020. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Schoelly Fiberoptic GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2020
- Date Received
- July 15, 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