KOH · Instrument, Manual, General Obstetric-Gynecologic
Obstetrics/Gynecology · 21 CFR 884.4520 · Class 1
Overview
| Product Code | KOH |
|---|---|
| Device Name | Instrument, Manual, General Obstetric-Gynecologic |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000212 | KSEA CHARDONNES MORCELLATION KNIFE | KARL STORZ Endoscopy-America, Inc. | Apr 21, 2000 | SESE |
| K921732 | MINOR LAP SET | Medikmark, Inc. | Jun 15, 1994 | SESE |
| K921730 | C-SECTION PACK | Medikmark, Inc. | Jun 15, 1994 | SESE |
| K892693 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Zinnanti Surgical Instruments, Inc. | May 11, 1989 | SESE |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | Simpson/Basye, Inc. | May 11, 1989 | SESE |
| K891035 | NEEDLE EXTENSIONS | Zinnanti Surgical Instruments, Inc. | Mar 22, 1989 | SESE |
| K891049 | ZEPPELIN SCISSORS | Zinnanti Surgical Instruments, Inc. | Mar 17, 1989 | SESE |
| K863610 | THE OB-GYN CONCEPTS VAGINAL ASPIRATOR | Ob/Gyn Concepts, Ltd. | Jan 7, 1987 | SESE |
| K840308 | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S | Imm Enterprises , Ltd. | Mar 5, 1984 | SESE |
| K823792 | QUARTZ RETRACTOR/PROBE | American V. Mueller | Jan 18, 1983 | SESE |
| K812204 | UTERINE MANIPULATORS | Reznik Instruments | Oct 13, 1981 | SESE |
| K800834 | SER-TEX | V.S.S.I., Inc. | Jun 30, 1980 | SESE |
| K790851 | VAGI-PRESS #401 | C. Intl. | Jul 30, 1979 | SESE |
| K781767 | INSTRUMENT CURNETT MINI-CONER BIOPSY | C.R. Bard, Inc. | Dec 7, 1978 | SESE |
| K780460 | DENTAL AIR BRUSH | M. Joel Gebhart, D.D.S. | Jun 28, 1978 | SESE |
Top Applicants
- Zinnanti Surgical Instruments, Inc. — 3 clearances
- Medikmark, Inc. — 2 clearances
- American V. Mueller — 1 clearance
- C. Intl. — 1 clearance
- C.R. Bard, Inc. — 1 clearance
