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Branson #1 Elevator

by The Tulip Mfg. Co.

510(k) K952932

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952932 Date14 Nov 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.