510(k) K110004
- Device
- ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
- Applicant
- ADVANCED SURGICAL CONCEPTS
- 510(k) number
- K110004
- Product code
- OTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-01-26
- Date received
- 2011-01-03
- Regulation
- 876.1500
- Classification name
- Laparoscopic Single Port Access Device
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JONATHAN KAHAN
- Address
- 355 Thirteenth St., NW Washington DC US 20004 20004
FDA Registration Numbers#
- 9611102
- 1220351
- 3010370500
- 1418479
- 2219920
- 3020347456
Source Documents#
Other 510(k) Records For Product Code OTJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232062 | Uni-port | Dalim Medical Corp. | 2024-01-16 |
| K220081 | CORE-SPORT | Incore Co., Ltd. | 2022-09-28 |
| K202688 | AFS Medical Sterile Single-Use Access Port System | Afs Medical Co. , Ltd. | 2021-10-14 |
| K160797 | FMX314 Surgical Platform | Fortimedix Surgical B.V. | 2016-08-26 |
| K152598 | Endo Keeper | Nelis | 2016-03-17 |
| K121309 | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE | Advanced Surgical Concepts | 2012-09-06 |
| 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 |
| K111407 | TRIPORT, TRIPORT+, TRIPORT15, QUADPORT | Advanced Surgical Concepts | 2012-01-18 |
| K112196 | OCTOTMPORT | Dalim Surgnet Corporation | 2011-09-14 |
| 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 |
Legacy Summary#
summary
FDA Review#
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