ASC TriPort+ Laparoscopic Access Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110004 FDA 510(k)
- FDA Product Code
- OTJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ASC TriPort+ Laparoscopic Access Device is a Laparoscopic Single Port Access Device, designed to facilitate minimally invasive abdominal surgery. It enables simultaneous insertion of multiple laparoscopic instruments and/or a camera through a single incision, reducing the number of trocar sites required. Constructed as a multi-instrument port, it integrates an introducer and a base retractor to expand the abdominal incision and accommodate instrument passage.
This device is supplied as a sterile, single-use product, intended for use in gastroenterology and urology procedures. It is classified under FDA 510(k) clearance (K110004) and falls under Device Class II (876.1500). The device is reusable only as specified by the manufacturer’s instructions and must be handled in accordance with standard surgical protocols. No MRI safety information is provided in the available data.
Frequently asked questions
What types of surgical procedures is the ASC TriPort+ Laparoscopic Access Device primarily used for, and why is it beneficial in those settings?
The ASC TriPort+ Laparoscopic Access Device is designed for use in gastroenterology and urology procedures, where minimally invasive abdominal surgery is required. It reduces the number of trocar sites by allowing multiple laparoscopic instruments and/or a camera to be inserted through a single incision, which minimizes patient trauma, shortens recovery time, and lowers the risk of complications associated with multiple entry points.
Is the ASC TriPort+ Laparoscopic Access Device intended for single-use or reusable applications, and what are the manufacturer’s guidelines for reuse?
The ASC TriPort+ Laparoscopic Access Device is sterile and intended for single-use only as supplied. However, the manufacturer’s instructions may allow for limited reuse under strict conditions, such as reprocessing per surgical protocols, though this is not explicitly detailed in the provided data. Always follow the manufacturer’s guidelines to ensure safety and compliance.
How does the ASC TriPort+ differ from traditional laparoscopic trocars in terms of functionality, and what specific features does it include?
Unlike traditional laparoscopic trocars, which require separate incisions for each instrument, the ASC TriPort+ is a multi-instrument port that combines an introducer and a base retractor. This design expands the abdominal incision to accommodate multiple instruments simultaneously through a single entry point, reducing surgical site disruption and improving efficiency in procedures like those in gastroenterology and urology.
What regulatory pathway was followed for FDA clearance of the ASC TriPort+ Laparoscopic Access Device, and what classification does it hold?
The ASC TriPort+ Laparoscopic Access Device received FDA clearance via a 510(k) submission (K110004), classified under Device Class II (876.1500). The clearance was determined under a Special 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This classification reflects its role as a Laparoscopic Single Port Access Device for minimally invasive surgery.
What storage or handling precautions should be taken with the ASC TriPort+ Laparoscopic Access Device before use?
Since the device is sterile and single-use, it should be stored in its original packaging until ready for use to maintain sterility. Follow standard surgical protocols for handling, including avoiding contamination, and adhere to the manufacturer’s instructions for preparation. No specific storage temperature or conditions are mentioned in the provided data, so consult the packaging or manufacturer guidelines for additional details.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Triport Plus - Advanced Surgical Concepts, PDF Special 510(k) Summary For the Advanced Surgical Concepts (ASC) TriPort ..., AccessGUDID - DEVICE: TriPort+ (05391530440073), ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (K110004) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110004 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Surgical Concepts
Sources (1)
- FDA 510(k) K110004 24 fields · synced Sep 20, 2026