Applied Gelport Laparoscopic Hand Access Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K014047 FDA 510(k)
- FDA Product Code
- GCJ 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 Applied Gelport Laparoscopic Hand Access Device is a laparoscopic hand access device designed to allow surgeons to alternate between hand access, straight laparoscopic, and open surgical techniques during procedures. It is intended to optimize procedural efficiency and clinical outcomes by providing access for rapid dissection and mobilization of tissue.
The device includes a GelSeal cap for unparalleled access and is used with the Alexis O wound protector-retractor for atraumatic retraction and protection. It is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization. The device received FDA 510(k) clearance (K014047) as substantially equivalent to a predicate device, with review by the Gastroenterology and Urology advisory committees.
Frequently asked questions
What is the Applied Gelport Laparoscopic Hand Access Device used for?
The device is designed to allow surgeons to alternate between hand access, straight laparoscopic, and open surgical techniques during procedures. It optimizes procedural efficiency and clinical outcomes by providing access for rapid dissection and mobilization of tissue.
Is the Applied Gelport Laparoscopic Hand Access Device sterile when supplied?
The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization. It must be properly reprocessed between uses to ensure patient safety.
What components are included with the Applied Gelport Laparoscopic Hand Access Device?
The device includes a GelSeal cap for unparalleled access and is used with the Alexis O wound protector-retractor for atraumatic retraction and protection. These components work together to support tissue handling and surgical access.
How was the Applied Gelport Laparoscopic Hand Access Device cleared for market?
The device received FDA 510(k) clearance (K014047) as substantially equivalent to a predicate device. Its submission was reviewed by the Gastroenterology and Urology advisory committees under a traditional review pathway.
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: GelPort Hand Access Laparoscopic System | Applied Medical, GelPort Hand Access Laparoscopic System | Applied Medical, GelPort® - Applied Medical - PDF Catalogs | Technical Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K014047 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K014047 24 fields · synced Sep 24, 2026