Branson Oversheath

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

Full name

The Tulip Company Branson Oversheath

510(k) Number

K952958 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• The Tulip Company Brason Nerve Hook & Dissector

  Class II

  FDA 510(k) K952951 Active Cleared 14 Nov 1995

• The Tulip Mono Polar Rotatable Metz Scissors

  Class II

  FDA 510(k) K955502 Active Cleared 17 Jan 1996

• Tulip Mono-Polar Cautery Spatula

  Class II

  FDA 510(k) K952973 Active Cleared 11 Sep 1995

• The Tulip Company Branson Straight Dissector

  Class II

  FDA 510(k) K952955 Active Cleared 30 Oct 1995

• The Tulip Laparoscope Sheath 6mm Single Stopcock

  Class II

  FDA 510(k) K952906 Active Cleared 22 Jan 1996

• The Tulip Company Branson Recurved Dissector

  Class II

  FDA 510(k) K952934 Active Cleared 30 Oct 1995

See all devices from The Tulip Mfg. Co. →

• What is the Branson Oversheath designed for?

  The Branson Oversheath is a protective covering specifically designed for laparoscopic instruments. It is intended for use in general surgery, plastic surgery, gastroenterology, and urology procedures. Its primary purpose is to reduce contamination risk and facilitate smooth insertion and manipulation of instruments within the body cavity during minimally invasive surgeries.

• Is the Branson Oversheath single-use or reusable?

  The Branson Oversheath is supplied as a single-use device. This design ensures sterility and reduces the risk of cross-contamination between patients, adhering to best practices for sterile medical devices.

• How should the Branson Oversheath be stored?

  The Branson Oversheath must be stored according to standard sterile medical device protocols to maintain its integrity before use. This includes keeping it in a sealed, sterile packaging until the time of use and protecting it from physical damage or contamination.

• What types of procedures is this oversheath approved for?

  The Branson Oversheath is approved for use in minimally invasive surgical applications, including general surgery, plastic surgery, gastroenterology, and urology procedures. Its classification under FDA regulation 876.1500 and advisory committee involvement in Gastroenterology and Urology procedures supports its intended use.

• What regulatory pathway was followed for this device?

  The Branson Oversheath received a 510(k) clearance (K952958) through the traditional review pathway, demonstrating it is substantially equivalent to a predicate device. This clearance was granted under FDA guidelines, classifying it as a Class II medical device.