FDA Product Code
FDA Product Code OTJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232062 | Uni-port | Dalim Medical Corp. | 2024-01-16 | Traditional | PDF ↗ |
| K220081 | CORE-SPORT | Incore Co., Ltd. | 2022-09-28 | Traditional | PDF ↗ |
| K202688 | AFS Medical Sterile Single-Use Access Port System | Afs Medical Co. , Ltd. | 2021-10-14 | Traditional | PDF ↗ |
| K160797 | FMX314 Surgical Platform | Fortimedix Surgical B.V. | 2016-08-26 | Traditional | PDF ↗ |
| K152598 | Endo Keeper | Nelis | 2016-03-17 | Traditional | PDF ↗ |
| K121309 | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE | Advanced Surgical Concepts | 2012-09-06 | Special | PDF ↗ |
| K120898 | KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA | Richard Wolf Medical Instruments Corp. | 2012-08-03 | Traditional | PDF ↗ |
| K111407 | TRIPORT, TRIPORT+, TRIPORT15, QUADPORT | Advanced Surgical Concepts | 2012-01-18 | Traditional | PDF ↗ |
| K112196 | OCTOTMPORT | Dalim Surgnet Corporation | 2011-09-14 | Special | PDF ↗ |
| K110004 | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE | Advanced Surgical Concepts | 2011-01-26 | Special | PDF ↗ |
| K101794 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA | Advanced Surgical Concepts | 2010-11-29 | Special | PDF ↗ |
Product code OTJ · Class II · Gastroenterology, Urology. Data: openFDA.