OTJ
11 FDA 510(k) clearances · Product code
156 daysmedian time to decision
261 days90th percentile
11clearances measured
FDA profile
- Official device name
- Laparoscopic Single Port Access Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
- Adverse events (MAUDE)
- 2012: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Uni-port (K232062) | Dalim Medical Corp. | 2024-01-16 |
| CORE-SPORT (K220081) | Incore Co., Ltd. | 2022-09-28 |
| AFS Medical Sterile Single-Use Access Port System (K202688) | Afs Medical Co. , Ltd. | 2021-10-14 |
| FMX314 Surgical Platform (K160797) | Fortimedix Surgical B.V. | 2016-08-26 |
| Endo Keeper (K152598) | Nelis | 2016-03-17 |
| ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE (K121309) | Advanced Surgical Concepts | 2012-09-06 |
| KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA (K120898) | Richard Wolf Medical Instruments Corp. | 2012-08-03 |
| TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (K111407) | Advanced Surgical Concepts | 2012-01-18 |
| OCTOTMPORT (K112196) | Dalim Surgnet Corporation | 2011-09-14 |
| ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (K110004) | Advanced Surgical Concepts | 2011-01-26 |
| ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA (K101794) | Advanced Surgical Concepts | 2010-11-29 |
Track OTJ automatically
Every clearance here is in the API, with alerts when new ones post.