510(k) K181127
K181127 is an FDA 510(k) premarket notification submitted by Interscope, Inc. for the device "EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control". The FDA issued a decision of Substantially Equivalent on January 3, 2019. 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
- January 3, 2019
- Date Received
- April 30, 2018
- 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)