Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System

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

510(k) Number

K220563 ↗

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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• What types of surgical procedures is the Ambient HipVac 50 Wand designed to assist with, and how does it achieve its effects?

  The Ambient HipVac 50 Wand is designed for soft tissue resection, ablation, and hemostasis during surgical procedures. It achieves these effects by delivering bipolar, high-frequency electrical energy through its connection to one of the compatible COBLATION system controllers (RF20000, WEREWOLF, or WEREWOLF+), enabling precise tissue manipulation and control.

• Is the Ambient HipVac 50 Wand a single-use or reusable device, and what does this mean for its use in the operating room?

  The Ambient HipVac 50 Wand is supplied as a reusable component, meaning it is intended to be cleaned, sterilized, and reused across multiple surgical procedures. This design allows for cost efficiency and reduces waste, though proper reprocessing protocols must be followed to ensure safety and functionality.

• What COBLATION system controllers are compatible with the Ambient HipVac 50 Wand, and how does this pairing work?

  The Ambient HipVac 50 Wand is designed to operate with three specific COBLATION system controllers: the RF20000, WEREWOLF, and WEREWOLF+. These controllers provide the high-frequency electrical energy required for the wand’s functions, enabling precise soft tissue resection, ablation, and hemostasis during surgery.

• What regulatory pathway was followed for the FDA clearance of this device, and what does this classification mean for its intended use?

  The Ambient HipVac 50 Wand received FDA 510(k) clearance under the Traditional pathway, classified under product code GEI (General, Plastic Surgery). This classification indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed for general plastic surgery applications as described in the device’s intended use.