510(k) K192905
K192905 is an FDA 510(k) premarket notification submitted by Creo Medical, Ltd. for the device "Creo Electrosurgical System with HS1 Hemostasis Accessory". The FDA issued a decision of Substantially Equivalent (kit) on March 19, 2020. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Creo Medical, Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 19, 2020
- Date Received
- October 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type