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reprocessed scissor tips
Sterilmed
Summary: Reprocessed scissor tips are surgical instrument components used in various procedures to ensure precision cutting. They are primarily used by surgeons in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K073613 ↗
Decision Date
February 12, 2008
Product Code
NUJ
Device Class
Class 2
Evidence
0 studies
The reprocessed scissor tips by Sterilmed were cleared through the FDA 510k pathway on February 12, 2008. They are classified as Class 2 devices under product code NUJ.
What It Is
Reprocessed scissor tips are components of surgical scissors that have been sterilized and prepared for reuse. These tips are crucial for maintaining the sharpness and precision required during surgical procedures. The reprocessing involves cleaning, sterilization, and quality checks to ensure they meet safety standards. This process helps reduce medical waste and costs while maintaining the functionality of surgical instruments.
Clinical Applications
Reprocessed scissor tips are commonly used in surgical settings, particularly in procedures requiring precise cutting, such as in general surgery, gynecology, and cardiovascular surgeries. They are essential in both inpatient and outpatient surgical centers. Surgeons rely on these instruments to perform delicate tasks, ensuring minimal tissue damage and optimal patient outcomes.
Indications for Use
The FDA indications suggest that these scissor tips are suitable for use in surgeries where precision cutting is necessary. They are intended for use in patients undergoing surgical procedures that require sharp, reliable cutting instruments.
Practical Considerations
Reprocessed scissor tips are typically available in various sizes to fit different types of surgical scissors. Compatibility with existing surgical instruments is crucial, so they are designed to match standard scissor models. Proper handling and sterilization techniques are essential to maintain their efficacy and safety.
Related Literature
The linked study focused on developing a 'Scissor-Tip-Separator' to prevent damage to scissor blades during steam sterilization. The study highlighted the challenge of maintaining blade sharpness, which is crucial for effective sterilization and patient safety. The new device was evaluated for its ability to keep blades separated, thus preventing damage. However, the study's limitations include a lack of extensive clinical trials to validate long-term efficacy.
Frequently Asked Questions
What is reprocessed scissor tips used for?
Reprocessed scissor tips are used in surgical procedures requiring precise cutting, ensuring sharpness and reliability of surgical scissors.
What specialties typically use this device?
Specialties such as general surgery, gynecology, and cardiovascular surgery commonly use reprocessed scissor tips.
What are the FDA-cleared indications?
The device is indicated for use in surgeries requiring precision cutting, ensuring sharpness and reliability of surgical instruments.
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.