OTJ — Laparoscopic Single Port Access Device Class II
FDA product code OTJ covers "Laparoscopic Single Port Access Device", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OTJ
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232062 | dalim medical | Uni-port | January 16, 2024 |
| K220081 | incore co | CORE-SPORT | September 28, 2022 |
| K202688 | afs medical co. | AFS Medical Sterile Single-Use Access Port System | October 14, 2021 |
| K160797 | fortimedix surgical | FMX314 Surgical Platform | August 26, 2016 |
| K152598 | nelis | Endo Keeper | March 17, 2016 |
| K121309 | advanced surgical concepts | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE | September 6, 2012 |
| K120898 | richard wolf medical instruments | KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR | August 3, 2012 |
| K111407 | advanced surgical concepts | TRIPORT, TRIPORT+, TRIPORT15, QUADPORT | January 18, 2012 |
| K112196 | dalim surgnet corporation | OCTOTMPORT | September 14, 2011 |
| K110004 | advanced surgical concepts | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE | January 26, 2011 |
| K101794 | advanced surgical concepts | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT | November 29, 2010 |