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 ?
Factors of "safety" and "effectiveness" are discussed in a 1998 FDA guidance document entitled "Procedures for Class II Device Exemptions from Premarket Notifi cation: Guidance for Industry and CDRH Staff.
The New Regulations removes record-filing for Class I device distributors and requires Class II device distributors to file records with the provincial CFDA.
Categorized as a Class II device for patient monitoring, the PhysIQ PPA software is the first FDA-cleared device to receive the new product code PLB: Automated calculation of a summary index based on several individual measured vital sign inputs.
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.
This was a trend discussed when I was over on the other side of the business--the traditional Class II device business.