Tulip Large Soft Tissue Retractor

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

Full name

The Tulip Large Soft Tissue Retractor

510(k) Number

K952980 ↗

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 types of surgical procedures is this retractor primarily used for, and why is it beneficial in those settings?

  The Tulip Large Soft Tissue Retractor is designed for general and plastic surgery, with specific applications in gastroenterology and urology procedures. It is particularly useful in these fields because it retracts soft tissue to provide controlled exposure of surgical sites, ensuring clear visualization and improved access for the surgeon during operations. This helps minimize tissue manipulation and reduces the risk of unintended trauma or obstruction.

• Is this retractor intended for single-use or reusable applications, and what does that mean for maintenance?

  This retractor is explicitly supplied as a reusable surgical instrument, meaning it is meant to be cleaned, sterilized, and reused multiple times in sterile operating room environments. Since it is reusable, proper maintenance—including thorough cleaning, sterilization, and inspection for wear—is essential to ensure safety, functionality, and compliance with surgical protocols.

• What are the key differences between this retractor and other retractors in the same product category?

  Unlike some retractors that may be designed for specific single-use applications or limited tissue types, the Tulip Large Soft Tissue Retractor is classified under product code GCJ and is FDA 510(k)-cleared for general and plastic surgery, with advisory committee input from Gastroenterology and Urology. Its design emphasizes controlled soft tissue retraction for broader procedural use, particularly in larger or more complex exposures where clear visualization is critical.

• How should this retractor be stored to maintain its integrity and readiness for use?

  Since this is a reusable instrument, it should be stored in a clean, dry, and protected environment—preferably in a dedicated surgical instrument tray or case—when not in use. After sterilization, it must be stored according to standard surgical protocols to prevent contamination or damage. The manufacturer’s instructions (not provided here) should specify any additional storage requirements, such as avoiding exposure to moisture or sharp objects.

• What does the FDA 510(k) clearance (K952980) under product code GCJ indicate about this device’s regulatory pathway?

  The FDA 510(k) clearance (K952980) with product code GCJ confirms that this retractor has been determined to be substantially equivalent to a legally marketed device already on the market. This classification means it meets FDA standards for safety and effectiveness in its intended surgical applications—specifically for retracting soft tissue in general, plastic, gastroenterology, and urology procedures—without requiring a new approval process beyond the 510(k) submission.