510(k) K243382
K243382 is an FDA 510(k) premarket notification submitted by Rz Medizintechnik GmbH for the device "RZ Resectoscope System". The FDA issued a decision of Substantially Equivalent on June 3, 2025. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Rz Medizintechnik GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2025
- Date Received
- October 31, 2024
- 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