E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
Device Facts
| Record ID | K921885 |
|---|---|
| Device Name | E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES |
| Applicant | Valleylab, Inc. |
| Product Code | HGZ · Obstetrics/Gynecology |
| Decision Date | Mar 25, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5390 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A perineal heater is a device designed to apply heat directly by contact, or indirectly from a radiant source, to the surface of the perineum (the area between the vulva and the anus) and is used to soothe or to help heal the perineum after an episiotomy (incision of the vulvar orifice for obstetrical purposes).
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 the limitations in § 884.9.
