Tulip Mono-Polar Cautery Spatula

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

Full name

The Tulip Mono-Polar Cautery Spatula

510(k) Number

K952973 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

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

• 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

• The Tulip Insulated Graspers

  Class II

  FDA 510(k) K952957 Active Cleared 30 Oct 1995

See all devices from The Tulip Mfg. Co. →

• What is the Tulip Mono-Polar Cautery Spatula used for?

  The Tulip Mono-Polar Cautery Spatula is designed for use with monopolar electrosurgical units to perform precise tissue cauterization and cutting during surgical procedures. It is particularly suited for general and plastic surgery applications, where controlled tissue manipulation is required to minimize bleeding and achieve clean incisions.

• How is the Tulip Mono-Polar Cautery Spatula supplied?

  This device is supplied sterile and intended for single-use in controlled surgical environments. The sterile packaging ensures it remains uncontaminated until use, adhering to best practices for surgical instruments to prevent infection and maintain procedural integrity.

• Is the Tulip Mono-Polar Cautery Spatula reusable?

  No, the Tulip Mono-Polar Cautery Spatula is explicitly designed for single-use only. Single-use devices are engineered to maintain sterility and performance for one surgical procedure, reducing the risk of cross-contamination and ensuring consistent results.

• What regulatory pathway does the Tulip Mono-Polar Cautery Spatula follow?

  The device follows the FDA 510(k) clearance pathway, with a clearance number of K952973. It was determined to be substantially equivalent to a predicate device and falls under the product code GEI, classified as an electrosurgical cutting and coagulation accessory. No third-party review was involved in this determination.

• What surgical specialties benefit most from using the Tulip Mono-Polar Cautery Spatula?

  The Tulip Mono-Polar Cautery Spatula is most beneficial in general surgery and plastic surgery. Its design allows for precise tissue control, which is critical in procedures requiring careful dissection, coagulation, and hemostasis, such as skin grafts, excisions, or reconstructive surgeries.