K220081 is an FDA 510(k) clearance for the CORE-SPORT. This device is classified as a Laparoscopic Single Port Access Device (Class II - Special Controls, product code OTJ).
Submitted by Incore Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 28, 2022, 261 days after receiving the submission on January 10, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery..
| 510(k) Number | K220081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2022 |
| Decision Date | September 28, 2022 |
| Days to Decision | 261 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. |