Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport Laparoscopic Asscess Device QPRT-01 (Wa
FDA 510(k) K101794 · Advanced Surgical Concepts
510(k) numberK101794
Submission
- Device name
- Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport Laparoscopic Asscess Device QPRT-01 (Wa
- Applicant
- Advanced Surgical Concepts
North Attleboro, MA, US - Received
- June 28, 2010
- Decision date
- November 29, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTJ – Laparoscopic Single Port Access Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
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| K160797 | FMX314 Surgical PlatformOTJ · Traditional | Fortimedix Surgical B.V. | 08/26/2016SE |
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| K121309 | Asc Quadport + Laparoscopic Access DeviceOTJ · Special | Advanced Surgical Concepts | 09/06/2012SE |
| K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…OTJ · Traditional | Richard Wolf Medical Instruments Corp. | 08/03/2012SE |
| K111407 | Triport, Triport+, TRIPORT15, QuadportOTJ · Traditional | Advanced Surgical Concepts | 01/18/2012SE |
| K112196 | OctotmportOTJ · Special | Dalim Surgnet Corporation | 09/14/2011SE |
| K110004 | Asc Triport+ Laparoscopic Access DeviceOTJ · Special | Advanced Surgical Concepts | 01/26/2011SE |
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| K232701 | Guardenia (GAR-1)GCJ · Special | 09/29/2023SE |
| K211234 | RedExGCJ · Traditional | 09/17/2021SE |
| K192898 | PneumoLinerPMU · Traditional | 02/25/2020SE |
| K121309 | Asc Quadport + Laparoscopic Access DeviceOTJ · Special | 09/06/2012SE |
| K111407 | Triport, Triport+, TRIPORT15, QuadportOTJ · Traditional | 01/18/2012SE |
| K110004 | Asc Triport+ Laparoscopic Access DeviceOTJ · Special | 01/26/2011SE |
| K073719 | Asc Triport Laparoscopic Access DeviceGCJ · Special | 01/29/2008SE |
| K073170 | R-Port II Laparoscopic Access DeviceGCJ · Traditional | 12/03/2007SE |
| K070158 | R-Port Laparoscopic Access DeviceGCJ · Traditional | 08/23/2007SE |
Questions and answers
When was Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport Laparoscopic Asscess Device QPRT-01 (Wa cleared by the FDA?
Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport Laparoscopic Asscess Device QPRT-01 (Wa (K101794) received a 510(k) decision of Substantially Equivalent on November 29, 2010, 154 days after the submission was received.
What is the product code of K101794?
The FDA product code is OTJ – Laparoscopic Single Port Access Device, a Class II (moderate risk) device regulated under 21 CFR 876.1500.