📊 Evidence-Based Reference
Resteril of Implant Elect Adapter
Telectronics
Summary: The resteril of implant elect adapter by Telectronics is a Class 3 device cleared by the FDA for use in specific clinical scenarios. Key evidence includes studies on its application in complex procedures, though detailed outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K772331 ↗
Decision Date ?
January 11, 1978
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The resteril of implant elect adapter was cleared through the FDA 510(k) pathway on January 11, 1978. It is manufactured by Telectronics and classified as a Class 3 device.
What It Is
The resteril of implant elect adapter is a medical device designed for use in conjunction with implantable electronic systems. It facilitates the connection and functionality of these systems in clinical settings.
FDA-Cleared Indications
- Use with implantable electronic systems as specified in the device labeling.
Clinical Applications
- Connecting compatible components of an implantable electronic system.
- Supporting the function or testing of an implantable electronic system in a clinical setting.
Evidence Summary
The available literature includes three studies, ranging from 1989 to 2021, encompassing various study types such as case reports and prospective studies. These studies explore the device's application in complex medical procedures.
Reported Outcomes
Published studies report limited specific outcomes related to the resteril of implant elect adapter. The focus has been on its role in facilitating complex procedures, but detailed efficacy data is not extensively documented in the provided studies.
Safety Profile
Reported complications include general concerns associated with implantable devices, though specific adverse events related to this adapter are not detailed in the available studies. Safety data remains limited.
Evidence Limitations
The evidence base for the resteril of implant elect adapter is limited, with a need for more comprehensive studies to better understand its efficacy and safety. Current literature lacks detailed outcome and safety data specific to this device.
Practical Considerations
- Use only with implantable electronic components confirmed to be compatible by the manufacturer or current device labeling.
- The available record does not specify dimensions, connector standards, electrical limits, or other compatibility details.
- MRI safety cannot be determined from the available FDA record; the device and the complete implanted system should be evaluated before MRI.
- Inspect the adapter and packaging for damage, and follow the labeled sterilization or reprocessing instructions when applicable.
- The available record does not establish a service life; durability depends on the device, implant system, handling, and clinical use.
Frequently Asked Questions
What are the clinical indications for resteril of implant elect adapter?
Clinical indications are detailed in the FDA documentation, primarily involving its use in conjunction with implantable electronic systems.
What outcomes have been reported in clinical studies?
Specific outcomes are not extensively documented; studies focus on the device's role in complex procedures.
What complications have been reported?
Safety data is limited, with general concerns related to implantable devices but no specific complications detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.