Panels › Gastroenterology, Urology › Product code OTJ · Class 2
Laparoscopic Single Port Access Device
Regulation 876.1500
0510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OTJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Surgical Concepts | 4 | 0 |
| Afs Medical Co. , Ltd. | 1 | 0 |
| Dalim Medical Corp. | 1 | 0 |
| Dalim Surgnet Corporation | 1 | 0 |
| Fortimedix Surgical B.V. | 1 | 0 |
| Incore Co., Ltd. | 1 | 0 |
| Nelis | 1 | 0 |
| Richard Wolf Medical Instruments Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2024 | K232062 | Uni-port Dalim Medical Corp., KR | OTJ |
| Sep 28, 2022 | K220081 | CORE-SPORT Incore Co., Ltd., KR | OTJ |
| Oct 14, 2021 | K202688 | AFS Medical Sterile Single-Use Access Port System Afs Medical Co. , Ltd., KR | OTJ |
| Aug 26, 2016 | K160797 | FMX314 Surgical Platform Fortimedix Surgical B.V., NL | OTJ |
| Mar 17, 2016 | K152598 | Endo Keeper Nelis, KR | OTJ |
| Sep 6, 2012 | K121309 | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts | OTJ |
| Aug 3, 2012 | K120898 | KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA Richard Wolf Medical Instruments Corp. | OTJ |
| Jan 18, 2012 | K111407 | TRIPORT, TRIPORT+, TRIPORT15, QUADPORT Advanced Surgical Concepts | OTJ |
| Sep 14, 2011 | K112196 | OCTOTMPORT Dalim Surgnet Corporation | OTJ |
| Jan 26, 2011 | K110004 | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts | OTJ |
| Nov 29, 2010 | K101794 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA Advanced Surgical Concepts | OTJ |
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