GelPoint Path Transanal Access Platform
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133393 FDA 510(k)
- FDA Product Code
- FER 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 GelPoint Path Transanal Access Platform is a device that provides flexible, air-tight fulcrum to facilitate triangulation of standard instrumentation for minimally invasive surgery. It enables insufflated access to the rectum and lower sigmoid colon for surgical procedures including TransAnal Minimally Invasive Surgery (TAMIS). This device is designed to increase the range of motion of instruments and maximize retraction and exposure.
The device is supplied for use in abdominal, transanal, and transvaginal procedures. It is authorized under FDA 510K clearance with product code FER and is classified as device class 2. The device is intended for use with standard laparoscopic instrumentation for resecting benign and malignant lesions in the distal to proximal rectum.
Frequently asked questions
What is the GelPoint Path Transanal Access Platform used for?
The GelPoint Path Transanal Access Platform provides a flexible, air-tight fulcrum to facilitate triangulation of standard instrumentation for minimally invasive surgery. It enables insufflated access to the rectum and lower sigmoid colon for procedures including TransAnal Minimally Invasive Surgery (TAMIS).
How is the GelPoint Path Transanal Access Platform supplied?
The device is supplied for use in abdominal, transanal, and transvaginal procedures. It is designed to increase the range of motion of instruments and maximize retraction and exposure during surgical procedures.
What is the regulatory status of the GelPoint Path Transanal Access Platform?
The device is authorized under FDA 510K clearance with product code FER and is classified as device class 2. It is intended for use with standard laparoscopic instrumentation for resecting benign and malignant lesions in the distal to proximal rectum.
Can the GelPoint Path Transanal Access Platform be reused?
The device information does not specify whether it is single-use or reusable. For proper usage and sterilization instructions, please refer to the manufacturer's guidelines or contact Applied Medical Resources Corp. directly.
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: GelPOINT Access Platforms | Applied Medical, GelPOINT Path Transanal Access Platform | Applied Medical, GelPOINT Path Transanal Procedural Pack | Applied Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133393 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K133393 24 fields · synced Sep 26, 2026