HDF · Speculum, Vaginal, Metal
Obstetrics/Gynecology · 21 CFR 884.4520 · Class 1
Overview
| Product Code | HDF |
|---|---|
| Device Name | Speculum, Vaginal, Metal |
| 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.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Thomasville Medical Assoc. | Feb 28, 1994 | SESE |
| K902019 | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS | Gynescope Corp. | Jun 7, 1990 | SESE |
| K891041 | MIYA SPECULUM | Zinnanti Surgical Instruments, Inc. | Mar 22, 1989 | SESE |
| K891044 | LASER SPECULA | Zinnanti Surgical Instruments, Inc. | Mar 17, 1989 | SESE |
| K890375 | VAGINAL SPECULUM | Kinetic Medical Products | Feb 13, 1989 | SESE |
| K862478 | HAYES VAGINAL SHIELD | Franklin Medical USA, Inc. | Nov 24, 1986 | SESE |
| K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL | Downs Surgical , Ltd. | Oct 29, 1985 | SESE |
| K851799 | 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA | Artiberia | May 22, 1985 | SESE |
| K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN | Downs Surgical , Ltd. | Oct 1, 1984 | SESE |
| K821297 | GRAVES SPECULA | Conphar, Inc. | May 24, 1982 | SESE |
| K821291 | PEDERSON VAGINAL SPECULA | Conphar, Inc. | May 24, 1982 | SESE |
Top Applicants
- Conphar, Inc. — 2 clearances
- Downs Surgical , Ltd. — 2 clearances
- Zinnanti Surgical Instruments, Inc. — 2 clearances
- Artiberia — 1 clearance
- Franklin Medical USA, Inc. — 1 clearance
