Branson #1 Elevator
510(k) K952932
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952932 | Date14 Nov 1995 | 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- Withdrawn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
- Full name
- The Tulip Company Branson #1 Elevator
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Branson #1 Elevator is a surgical instrument classified as a laparoscope accessory under the FDA’s classification name for general and plastic surgery devices. It is designed to assist in minimally invasive procedures by facilitating tissue manipulation and retraction within the abdominal or pelvic cavity. This device is intended for use in conjunction with laparoscopic techniques, aiding surgeons in visualizing and accessing internal structures during procedures such as hernia repairs, cholecystectomies, or other abdominal surgeries.
The Branson #1 Elevator is supplied as a reusable surgical instrument, intended for use in sterile operating room environments. It is regulated under FDA’s 510(k) clearance (K952932) and falls under product code GCJ, with a classification under regulation 876.1500. No specific MRI safety or sterility requirements beyond standard surgical instrument processing are noted in the regulatory submission. The device is intended for use in gastroenterology and urology procedures, as reviewed by the Gastroenterology/Urology advisory committee.
Other devices from The Tulip Mfg. Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Branson #1 Elevator used for in surgical procedures?
The Branson #1 Elevator is designed as a laparoscope accessory to assist surgeons during minimally invasive procedures. It helps with tissue manipulation and retraction within the abdominal or pelvic cavity, improving visualization and access to internal structures. This is particularly useful in surgeries such as hernia repairs, cholecystectomies, and other abdominal or pelvic procedures where precise control of tissue is required.
Is the Branson #1 Elevator reusable or single-use?
The Branson #1 Elevator is supplied as a reusable surgical instrument. It is intended for use in sterile operating room environments, meaning it must undergo proper cleaning, sterilization, and maintenance between procedures to ensure safety and functionality.
What regulatory pathway does the Branson #1 Elevator follow?
The Branson #1 Elevator is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K952932. It is classified under product code GCJ and falls under the regulation 876.1500 for general and plastic surgery devices. The device was reviewed by the Gastroenterology/Urology advisory committee and determined to be substantially equivalent to a predicate device.
What types of procedures is this elevator intended for?
This elevator is intended for use in minimally invasive laparoscopic procedures, including but not limited to hernia repairs, cholecystectomies, and other abdominal or pelvic surgeries. Its design aids in tissue manipulation and retraction, making it suitable for procedures where clear visualization and controlled access to internal structures are critical.
Are there any special storage or handling requirements for the Branson #1 Elevator?
While no specific MRI safety or sterility requirements beyond standard surgical instrument processing are noted, the Branson #1 Elevator must be stored in a clean, dry environment to prevent contamination. As a reusable instrument, it should be kept in a dedicated case or packaging to maintain its integrity and readiness for sterilization before each use.