Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart D — Obstetrical and Gynecological Prosthetic Devices](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices) → [21 CFR 884.3200](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/884.3200) → HFL — Drain, Cervical

# HFL · Drain, Cervical

_Obstetrics/Gynecology · 21 CFR 884.3200 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL

## Overview

- **Product Code:** HFL
- **Device Name:** Drain, Cervical
- **Regulation:** [21 CFR 884.3200](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/884.3200)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL/K903989.md) | SIL-MED T-TUBE DRAIN | Sil-Med Corp. | Jan 31, 1991 | SESE |

## Top Applicants

- Sil-Med Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL)

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