Identifiers
- 510(k) Number
- K131375 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 Autolap System is a device used in laparoscopic surgery for image-guided robotic laparoscope positioning. It is a software-based image analytics information platform that provides advanced visualization, scene recognition, and data analytics.
The system is supplied as part of a medical robotics and computer-assisted surgery (MRCAS) platform. It received FDA 510(k) clearance (K131375) on September 19, 2013, and is classified under product code GCJ with advisory committee review in Gastroenterology and Urology.
Frequently asked questions
What is the Autolap System used for?
The Autolap System is used in laparoscopic surgery for image-guided robotic laparoscope positioning. It functions as a software-based image analytics information platform that provides advanced visualization, scene recognition, and data analytics to assist surgeons during procedures.
How is the Autolap System supplied and what type of device is it?
The Autolap System is supplied as part of a medical robotics and computer-assisted surgery (MRCAS) platform. It is a software-based image analytics platform, not a physical instrument, and is designed to integrate with robotic systems to enhance laparoscopic visualization and control.
Does the Autolap System have FDA clearance and what is its classification?
Yes, the Autolap System received FDA 510(k) clearance (K131375) on September 19, 2013. It is classified under product code GCJ and underwent advisory committee review in Gastroenterology and Urology, with a traditional clearance pathway and a substantially equivalent decision.
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: PDF M.S.T. - Medical Surgery Technologies Ltd. is a privately ... - Kebomed, MST - Medical Surgery Technologies - LinkedIn, K131375 FDA 510 (k) - AUTOLAP SYSTEM, AUTOLAP SYSTEM (K131375) — FDA 510(k) | Innolitics, Medical Surgery Technologies — Health Tech & Life Sciences | Finder - MST
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131375 | Class II | Active |
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Manufacturer
- Manufacturer
- Mst - Medical Surgery Technologies , Ltd.
Sources (1)
- FDA 510(k) K131375 24 fields · synced Sep 21, 2026