510(k) K254303
K254303 is an FDA 510(k) premarket notification submitted by Karl Storz SE & CO. KG for the device "KARL STORZ SUPRALOOP". The FDA issued a decision of Substantially Equivalent on Sep 24, 2026. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Karl Storz SE & CO. KG has 33 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 24, 2026
- Date Received
- Dec 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4160
- Review Panel
- OB
- Submission Type
- 510(k)