Bovie Model X15

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

510(k) Number

K972161 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Eudermic Hypoallergenic Surgical Gloves/Eudermic Surgical Gloves (Various)

  Class I

  FDA 510(k) K964440 Active Cleared 22 Apr 1997

• Vessel Dilator

  Class II

  FDA 510(k) K963388 Active Cleared 11 Mar 1997

• Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove

  Class I

  FDA 510(k) K991615 Active Cleared 30 Jul 1999

• Sniper Elite Model-Or-E3872XX Series

  Class II

  FDA 510(k) K011905 Active Cleared 28 Aug 2001

• Sterile Sensicare Advantix Powder Free Polyurethane Medical/Dental Examination Glove

  Class I

  FDA 510(k) K021452 Active Cleared 1 Aug 2002

• Sensicare Synthetic Powder Free Surgical Gloves (Poly Isoprene)

  Class I

  FDA 510(k) K010297 Active Cleared 16 Feb 2001

See all devices from Maxxim Medical →

• What is the Bovie Model X15 used for?

  The Bovie Model X15 provides high-frequency electrical energy for cutting and coagulation of human tissue during laparoscopic and general surgical procedures, operated by surgeons in clinical or operating room settings.

• Is the Bovie Model X15 reusable or single-use?

  The Bovie Model X15 is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and sterilization between procedures, in accordance with manufacturer instructions.

• How was the Bovie Model X15 authorized for use in the United States?

  The Bovie Model X15 was cleared through the FDA 510(k) process under product code GEI, demonstrating substantial equivalence to a predicate device, which allowed its legal marketing and use in the United States.