510(k) K011178
K011178 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR". The FDA issued a decision of Substantially Equivalent on May 4, 2001. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2001
- Date Received
- April 17, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Biliary Mechanical
- Device Class
- Class II
- Regulation Number
- 876.4500
- Review Panel
- GU
- Submission Type