K151567 is an FDA 510(k) clearance for the ENDOPLUS hand-held laparoscopic instruments, a Coagulator, Culdoscopic (and Accessories) (Class II — Special Controls, product code HFI), submitted by Endoplus (Mundelein, US). The FDA issued a Cleared decision on December 23, 2015, 196 days after receiving the submission on June 10, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K151567 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 2015 |
| Decision Date | December 23, 2015 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFI — Coagulator, Culdoscopic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4160 |