510(k) K121343
K121343 is an FDA 510(k) premarket notification submitted by Atc Technologies, Inc. for the device "MODULAP LOOP". The FDA issued a decision of Substantially Equivalent on June 14, 2013. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Atc Technologies, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2013
- Date Received
- May 4, 2012
- 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