HFL · Drain, Cervical
Obstetrics/Gynecology · 21 CFR 884.3200 · Class 2
Overview
| Product Code | HFL |
|---|---|
| Device Name | Drain, Cervical |
| Regulation | 21 CFR 884.3200 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K903989 | SIL-MED T-TUBE DRAIN | Sil-Med Corp. | Jan 31, 1991 | SESE |
Top Applicants
- Sil-Med Corp. — 1 clearance
