K181127 is an FDA 510(k) clearance for the EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control. This device is classified as a Endoscopic Morcellator Gastroenterology (Class II - Special Controls, product code PTE).
Submitted by Interscope, Inc. (Whitinsville, US). The FDA issued a Cleared decision on January 3, 2019, 248 days after receiving the submission on April 30, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.1690. For Use In Endoscopic Procedures By A Trained Gastroenterologist To Resect And Remove Residual Tissue From The Peripheral Margins Following Emr (endoscopic Mucosal Resection).
| 510(k) Number | K181127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2018 |
| Decision Date | January 03, 2019 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PTE - Endoscopic Morcellator Gastroenterology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |
| Definition | For Use In Endoscopic Procedures By A Trained Gastroenterologist To Resect And Remove Residual Tissue From The Peripheral Margins Following Emr (endoscopic Mucosal Resection) |