Spacemaker Pro Access and Dissector System
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K151356 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 Spacemaker Pro Access and Dissector System is a modular surgical device designed for laparoscopic procedures, combining three dissectors and two balloon access devices. It is classified under the nomenclature for laparoscopic surgical instruments and is intended to facilitate tissue dissection and access during inguinal and abdominal wall repairs. The integrated system streamlines surgical workflow by providing a cohesive set of tools for both dissection and entry.
This system is supplied as a reusable medical device and is intended for use in controlled surgical environments, such as operating rooms. It is regulated under FDA 510(k) clearance (K151356) and falls under the advisory committee for Gastroenterology and Urology, with a special clearance type. The modular design includes specific dissector and access components, ensuring compatibility with laparoscopic techniques. Storage and handling follow standard surgical instrument protocols to maintain sterility and functionality.
Frequently asked questions
What is the Spacemaker Pro Access and Dissector System used for?
This system is designed for laparoscopic procedures, specifically to assist in tissue dissection and access during inguinal and abdominal wall repairs. The modular combination of dissectors and balloon access devices streamlines the surgical workflow by providing integrated tools for both entry and dissection, reducing the need for multiple separate instruments.
Is the Spacemaker Pro Access and Dissector System reusable or single-use?
The Spacemaker Pro Access and Dissector System is supplied as a reusable medical device. It is intended for use in controlled surgical environments like operating rooms, where standard surgical instrument protocols are followed to maintain sterility and functionality across multiple procedures.
How does the modular design benefit laparoscopic surgeries?
The modular design ensures compatibility with laparoscopic techniques by offering specific dissector and access components tailored for the procedure. This cohesive set of tools simplifies workflow by reducing the need to switch between different instruments, thereby improving efficiency and precision during inguinal and abdominal wall repairs.
What regulatory pathway does the Spacemaker Pro Access and Dissector System follow?
The system is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K151356. It was reviewed by the Gastroenterology and Urology (GU) advisory committee under the Special clearance type, with a decision of Substantially Equivalent (SESE) in 2015.
How should the Spacemaker Pro Access and Dissector System be stored?
Storage and handling of the Spacemaker Pro Access and Dissector System follow standard surgical instrument protocols to preserve sterility and functionality. This includes proper cleaning, disinfection, and storage in a clean, dry environment to ensure readiness for reuse in subsequent procedures.
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: Spacemaker™ Pro Access & Dissector System | Medtronic, Spacemaker™ Pro Access & Dissector System - Medtronic, Covidien Spacemaker Pro SMBTTOVLX Access and Dissector System, K151356 - Spacemaker Pro Access and Dissector System, COVIDIEN: SMBTTRNDX Geosurgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151356 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K151356 24 fields · synced Oct 1, 2026