K152598 is an FDA 510(k) clearance for the Endo Keeper, a Laparoscopic Single Port Access Device (Class II — Special Controls, product code OTJ), submitted by Nelis (Bucheon, KR). The FDA issued a Cleared decision on March 17, 2016, 188 days after receiving the submission on September 11, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K152598 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 2015 |
| Decision Date | March 17, 2016 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OTJ — Laparoscopic Single Port Access Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery. |