Tulip Disposable Cannulas
510(k) K060089
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060089 | Date27 Apr 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QPB
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.5040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Tulip Disposable Cannulas are classified as a System, Suction, Lipoplasty for Removal device, designed for use in lipoplasty procedures to remove fat through suction-assisted techniques. These cannulas are intended for aesthetic body contouring, facilitating precise fat removal during minimally invasive surgical interventions.
These single-use, disposable cannulas are supplied sterile and intended for use in controlled clinical settings. They are manufactured in various sizes as indicated by their registration numbers and are regulated under FDA 510(k) clearance (K060089) with a classification of Class II. No MRI safety information is specified, and they are not intended for reusable applications.
Questions
AI-generated answers, 19 Sep 2026
Are the Tulip Disposable Cannulas reusable or intended for single-use only, and why does this matter for my procedure?
The Tulip Disposable Cannulas are explicitly designed for single-use only, as stated in the manufacturer’s description. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in lipoplasty procedures where precision and infection control are paramount. Since they are supplied sterile, reusing them would violate their intended use and could compromise patient safety.
What sizes are available for the Tulip Disposable Cannulas, and how do I determine the right one for my patient?
The cannulas come in multiple sizes, each identified by unique registration numbers (e.g., 1058584, 3004112621, etc.). While the exact measurements aren’t listed, the variety suggests options for different lipoplasty techniques—thinner cannulas for finer contouring and larger ones for bulk fat removal. Consulting the manufacturer’s sizing guide or your surgical team’s experience with these specific models will help select the appropriate size for your patient’s anatomy and procedure goals.
How should I store the Tulip Disposable Cannulas before use, and is there any special handling required?
Since the cannulas are sterile and single-use, they should be stored in their original, sealed packaging until ready for use. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these could compromise sterility. The packaging likely includes instructions for opening and handling—always follow those to maintain a sterile field during your procedure.
What regulatory pathway was followed for FDA clearance of these cannulas, and what does that mean for my practice?
The Tulip Disposable Cannulas received FDA 510(k) clearance (K060089) under the *Traditional* review pathway, with a determination of Substantially Equivalent to a predicate device. This means the FDA evaluated them against an existing, legally marketed device and found they meet the same safety and effectiveness standards. For your practice, this clearance indicates the device complies with U.S. regulations for lipoplasty use, but you should still follow your facility’s protocols for sterile technique and proper disposal.