510(k) K170120
K170120 is an FDA 510(k) premarket notification submitted by Interscope, Inc. for the device "EndoRotor". The FDA issued a decision of Substantially Equivalent on April 18, 2017. The device falls under product code PTE (Endoscopic Morcellator Gastroenterology), a Class II device regulated under 21 CFR 884.1690. Interscope, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2017
- Date Received
- January 13, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Morcellator Gastroenterology
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- GU
- Submission Type
For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)