NEWPORT LATERAL VAGINAL RETRACTOR
Device Facts
| Record ID | K891351 |
|---|---|
| Device Name | NEWPORT LATERAL VAGINAL RETRACTOR |
| Applicant | Simpson/Basye, Inc. |
| Product Code | KOH · Obstetrics/Gynecology |
| Decision Date | May 11, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.4520 |
| Device Class | Class 1 |
Regulatory Classification
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.
