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implantible suture sleeve
Intermedics
Summary: The implantable suture sleeve by Intermedics is a device used to secure sutures in place during surgical procedures. It is typically used by surgeons in various specialties to ensure suture stability.
FDA Clearance Information
Pathway
510K
Number
K820487 ↗
Decision Date
April 16, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable suture sleeve by Intermedics was cleared through the FDA 510k pathway on April 16, 1982. It is classified as a Class III device under product code DTB.
What It Is
The implantable suture sleeve is a medical device designed to provide secure anchoring for sutures during surgical procedures. It is typically made of biocompatible materials that allow it to be safely implanted in the body. The device works by enveloping the suture material, preventing slippage and ensuring the stability of the surgical repair. This is particularly useful in procedures where suture integrity is critical.
Clinical Applications
This device is commonly used in surgical settings where maintaining suture stability is crucial, such as in cardiovascular, orthopedic, and general surgeries. Surgeons use it to enhance the security of sutures in procedures involving soft tissue repair or reconstruction. It is particularly beneficial in complex surgeries where suture failure could lead to significant complications.
Indications for Use
The implantable suture sleeve is indicated for use in patients requiring enhanced suture stability during surgical procedures. It is suitable for conditions where suture slippage could compromise surgical outcomes, such as in delicate tissue repairs.
Practical Considerations
The device is available in various sizes to accommodate different surgical needs and is compatible with standard suture materials. Surgeons should be familiar with the specific technique for implanting the sleeve to ensure optimal performance and patient outcomes.
Frequently Asked Questions
What is the implantable suture sleeve used for?
It is used to secure sutures in place during surgical procedures, preventing slippage and ensuring stability.
What specialties typically use this device?
Surgeons in cardiovascular, orthopedic, and general surgery specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in surgeries requiring enhanced suture stability to prevent slippage and ensure successful outcomes.
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.