SIMPULSE SOLO SUCTION IRRIGATOR
Device Facts
| Record ID | K942886 |
|---|---|
| Device Name | SIMPULSE SOLO SUCTION IRRIGATOR |
| Applicant | Davol Inc., Sub. C. R. Bard, Inc. |
| Product Code | FQH · General Hospital |
| Decision Date | Jul 19, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5475 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
