510(k) K103326
K103326 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "MULTIPLE BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 6, 2011. The device falls under product code FCK (Instrument, Biopsy, Suction), a Class II device regulated under 21 CFR 876.1075. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2011
- Date Received
- November 12, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy, Suction
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type