Laparoscopic Single Port Access Device
FDA product code OTJ · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
11510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232062 | Uni-portOTJ · Traditional | Dalim Medical Corp. | 01/16/2024SE |
| K220081 | Core-SportOTJ · Traditional | Incore Co., Ltd. | 09/28/2022SE |
| K202688 | AFS Medical Sterile Single-Use Access Port SystemOTJ · Traditional | Afs Medical Co. , Ltd. | 10/14/2021SE |
| K160797 | FMX314 Surgical PlatformOTJ · Traditional | Fortimedix Surgical B.V. | 08/26/2016SE |
| K152598 | Endo KeeperOTJ · Traditional | Nelis | 03/17/2016SE |
| K121309 | Asc Quadport + Laparoscopic Access DeviceOTJ · Special | Advanced Surgical Concepts | 09/06/2012SE |
| K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…OTJ · Traditional | Richard Wolf Medical Instruments Corp. | 08/03/2012SE |
| K111407 | Triport, Triport+, TRIPORT15, QuadportOTJ · Traditional | Advanced Surgical Concepts | 01/18/2012SE |
| K112196 | OctotmportOTJ · Special | Dalim Surgnet Corporation | 09/14/2011SE |
| K110004 | Asc Triport+ Laparoscopic Access DeviceOTJ · Special | Advanced Surgical Concepts | 01/26/2011SE |
| K101794 | Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport…OTJ · Special | Advanced Surgical Concepts | 11/29/2010SE |