K180134 is an FDA 510(k) clearance for the Ensizor Monopolar Endoscopic Scissors, a Forceps, Biopsy, Electric (Class II — Special Controls, product code KGE), submitted by Slater Endoscopy, LLC (Miami Lakes, US). The FDA issued a Cleared decision on June 29, 2018, 163 days after receiving the submission on January 17, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K180134 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 17, 2018 |
| Decision Date | June 29, 2018 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGE — Forceps, Biopsy, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |