K101794 is an FDA 510(k) clearance for the ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA. This device is classified as a Laparoscopic Single Port Access Device (Class II - Special Controls, product code OTJ).
Submitted by Advanced Surgical Concepts (North Attleboro, US). The FDA issued a Cleared decision on November 29, 2010, 154 days after receiving the submission on June 28, 2010.
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 | K101794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2010 |
| Decision Date | November 29, 2010 |
| Days to Decision | 154 days |
| Submission Type | Special |
| 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. |