HGD · Applicator, Vaginal
Obstetrics/Gynecology · 21 CFR 884.4520 · Class 1
Overview
| Product Code | HGD |
|---|---|
| Device Name | Applicator, Vaginal |
| Regulation | 21 CFR 884.4520 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes. (2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina. (3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina. (4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord. (5) A uterine clamp is an instrument used to hold the uterus by compression. (6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina. (7) A vaginal applicator is an instrument used to insert medication into the vagina. (8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue. (9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid. (10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.
Classification Rationale
Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823517 | THE KLINE APPLICATOR | Kline Technologies, Ltd. | Jan 18, 1983 | SESE |
Top Applicants
- Kline Technologies, Ltd. — 1 clearance
