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 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART F—General Hospital and Personal Use Therapeutic Devices (§880.5025 to §880.5970) > 880.5475—Jet lavage.

880.5475—Jet lavage.

(a) Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Code of Federal Regulations

[45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]