510(k) K223520
K223520 is an FDA 510(k) premarket notification submitted by Karl Storz-Endoscopy-America, Inc. for the device "UNIDRIVE SIII System". The FDA issued a decision of Substantially Equivalent on April 27, 2023. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Karl Storz-Endoscopy-America, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2023
- Date Received
- November 23, 2022
- 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