510(k) K111751
K111751 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS". The FDA issued a decision of Substantially Equivalent on December 2, 2011. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2011
- Date Received
- June 22, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4150
- Review Panel
- OB
- Submission Type