Suction Cautery Probe

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K955352 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Mectra Labs, Inc. →

• What types of surgical procedures is this suction cautery probe designed for, and how does it differ from standard electrosurgical tools?

  The Suction Cautery Probe by Mectra Labs, Inc. is specifically designed for general and plastic surgery procedures. Unlike standard electrosurgical tools, it combines suction and cautery functions, allowing surgeons to simultaneously remove tissue and control bleeding during surgery. This dual functionality streamlines procedures where both excision and hemostasis are required, reducing the need for separate instruments.

• Is this device single-use or reusable, and what sterilization requirements apply?

  This device is reusable and must be properly sterilized between uses. Since it is intended for repeated surgical applications, adherence to strict sterilization protocols is critical to prevent cross-contamination. The manufacturer does not specify single-use, so it is essential to follow facility guidelines for cleaning and sterilization to maintain safety and functionality.

• How was the FDA clearance for this device determined, and what does ‘Substantially Equivalent’ mean in this context?

  The Suction Cautery Probe received FDA 510(k) clearance (K955352) under the Traditional pathway, with a decision labeled as ‘Substantially Equivalent’ (SESE). This means the FDA determined that the device is as safe and effective as a legally marketed predicate device (a previously cleared suction cautery probe) without introducing new risks. The clearance was granted after a review by the Surgical Devices (SU) Advisory Committee in 1996.

• Are there any special considerations for storage or handling of this device?

  While the provided data does not specify storage conditions, as a reusable electrosurgical instrument, it should be stored in a clean, dry environment to prevent damage or contamination. After sterilization, it should be kept in a sealed, protective case or packaging to maintain sterility until use. Always follow manufacturer and facility protocols for handling to ensure optimal performance and longevity.