Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4520](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4520) → KOH — Instrument, Manual, General Obstetric-Gynecologic # KOH · Instrument, Manual, General Obstetric-Gynecologic _Obstetrics/Gynecology · 21 CFR 884.4520 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH ## Overview - **Product Code:** KOH - **Device Name:** Instrument, Manual, General Obstetric-Gynecologic - **Regulation:** [21 CFR 884.4520](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4520) - **Device Class:** 1 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) ## 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](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K000212.md) | KSEA CHARDONNES MORCELLATION KNIFE | KARL STORZ Endoscopy-America, Inc. | Apr 21, 2000 | SESE | | [K921732](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K921732.md) | MINOR LAP SET | Medikmark, Inc. | Jun 15, 1994 | SESE | | [K921730](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K921730.md) | C-SECTION PACK | Medikmark, Inc. | Jun 15, 1994 | SESE | | [K892693](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K892693.md) | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Zinnanti Surgical Instruments, Inc. | May 11, 1989 | SESE | | [K891351](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K891351.md) | NEWPORT LATERAL VAGINAL RETRACTOR | Simpson/Basye, Inc. | May 11, 1989 | SESE | | [K891035](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K891035.md) | NEEDLE EXTENSIONS | Zinnanti Surgical Instruments, Inc. | Mar 22, 1989 | SESE | | [K891049](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K891049.md) | ZEPPELIN SCISSORS | Zinnanti Surgical Instruments, Inc. | Mar 17, 1989 | SESE | | [K863610](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K863610.md) | THE OB-GYN CONCEPTS VAGINAL ASPIRATOR | Ob/Gyn Concepts, Ltd. | Jan 7, 1987 | SESE | | [K840308](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K840308.md) | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S | Imm Enterprises , Ltd. | Mar 5, 1984 | SESE | | [K823792](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K823792.md) | QUARTZ RETRACTOR/PROBE | American V. Mueller | Jan 18, 1983 | SESE | | [K812204](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K812204.md) | UTERINE MANIPULATORS | Reznik Instruments | Oct 13, 1981 | SESE | | [K800834](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K800834.md) | SER-TEX | V.S.S.I., Inc. | Jun 30, 1980 | SESE | | [K790851](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K790851.md) | VAGI-PRESS #401 | C. Intl. | Jul 30, 1979 | SESE | | [K781767](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K781767.md) | INSTRUMENT CURNETT MINI-CONER BIOPSY | C.R. Bard, Inc. | Dec 7, 1978 | SESE | | [K780460](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH/K780460.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/KOH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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