21 CFR 884.3200 — Drain, Cervical
Obstetrics/Gynecology (OB) · Part 884 Subpart D—Obstetrical and Gynecological Prosthetic Devices · § 884.3200
Identification
A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HFL | Drain, Cervical | 2 | 1 |
Special Controls
HFL — Drain, Cervical
*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.
eCFR
