510(k) K261706
K261706 is an FDA 510(k) premarket notification submitted by KARL STORZ SE & CO. KG for the device "Endomat Select (UP220)". The FDA issued a decision of Substantially Equivalent on July 16, 2026. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. KARL STORZ SE & CO. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2026
- Date Received
- May 22, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Hysteroscopic
- Device Class
- Class II
- Regulation Number
- 884.1700
- Review Panel
- OB
- Submission Type