CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART E—Neurological Surgical Devices (§882.4030 to §882.4900) > 882.4800—Self-retaining retractor for neurosurgery.

882.4800—Self-retaining retractor for neurosurgery.

(a) Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.
(b) Classification. Class II (performance standards).