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ball tip model 030-188
Med Telectronics
Summary: The ball tip model 030-188 by Med Telectronics is a Class 3 medical device used primarily in clinical settings for procedures involving IVC filters. Key evidence highlights its role in detecting bony pedicle defects.
FDA Clearance Information
Pathway
510K
Number
K770285 ↗
Decision Date
February 24, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The ball tip model 030-188 was cleared through the FDA 510k pathway on February 24, 1977. It is manufactured by Med Telectronics and classified as a Class 3 device.
What It Is
The ball tip model 030-188 is a specialized medical device designed for use in procedures involving inferior vena cava (IVC) filters. It aids in the detection of anatomical defects, enhancing surgical precision.
Clinical Applications
Commonly used in orthopedic and vascular procedures, the ball tip model 030-188 assists clinicians in identifying structural anomalies. It is particularly useful in surgeries requiring precise detection of bony defects.
Evidence Summary
The available literature includes 10 studies, encompassing various types such as RCTs and case series, published between 2021 and 2025. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the ball tip model 030-188 effectively aids in the detection of bony pedicle defects, with outcomes varying based on the surgeon's experience. The device's role in enhancing palpation quality is noted in clinical settings.
Safety Profile
Reported complications include challenges in palpation quality depending on the user's experience level. No significant adverse events have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish standardized protocols and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for ball tip model 030-188?
The device is indicated for use in procedures involving IVC filters, particularly for detecting bony pedicle defects.
What outcomes have been reported in clinical studies?
Studies report effective detection of anatomical defects, with outcomes influenced by the clinician's experience.
What complications have been reported?
Safety data indicate challenges in palpation quality, with no major adverse events reported.
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.