class II device

A ‘medium risk’ medical device—e.g., hearing aids, syringes—approved by the FDA for use in humans

class II device

Regulatory affairs A 'medium risk' medical device–eg, hearing aids, syringes, approved by the FDA for use in humans. See 510(K. ).
References in periodicals archive ?
Through the premarket notification process, the manufacturer of a Class II device must demonstrate that the device it intends to market is substantially equivalent to a device that is legally marketed.
A new Class II device will also be cleared if the manufacturer can show that it is "substantially equivalent" to a device that is already on the market.
Gerard Vanacker, founder and CEO, SpineVision(R) has announced that its proprietary technology, PediGuard(TM), the first and only FDA-cleared Class II device for real-time electronic detection of possible penetration outside the vertebral pedicle, was recently used in the 1000th spine surgery procedure since its launch.
A transparent tube composed of the copolyester poly(DL-lactide-[epsilon]-caprolactone), this FDA class II device is designed to treat peripheral nerve traumas requiring surgical intervention, facilitating the nerve reconnection procedure and improving nerve function recovery.
Neurolac is an FDA class II device that is a bioresorbable tube sutured to both ends of the transected nerve and guides the outgoing nerve in a protective environment.
For most Class I or Class II device studies, IVD manufacturers traditionally work directly with the laboratory, and not a clinician, to obtain desired samples.
Surgical mesh products are currently regulated by the FDA as a class II device, which requires the manufacturers to show that the product is substantially equivalent to a similar product already on the market.
5440, the FDA considers equipment that can simultaneously fill cylinders and provide oxygen directly to the hospital to be a class II device and therefore requires FDA marketing clearance.
The iThermonitor, a FDA class II device, continuously captures body temperature and automatically transmits the data wirelessly to mobile devices and cloud storage.
The Memphis, TN-based company's Prestige Disc, a stainless steel device, was approved as a Class II device.
As AMIC recently announced, the FDA has determined that the RadioGel(TM) brachytherapy product is a Class III medical device, unless reclassified as a Class II device.