← [Obstetrics/Gynecology](/submissions/OB) · Product Code HDF # HDF · Speculum, Vaginal, Metal _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/HDF ## Overview - **Product Code:** HDF - **Device Name:** Speculum, Vaginal, Metal - **Regulation:** 21 CFR 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. ## Cleared Devices (11) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K926429](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K926429.md) | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Thomasville Medical Assoc. | Feb 28, 1994 | SESE | | [K902019](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K902019.md) | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS | Gynescope Corp. | Jun 7, 1990 | SESE | | [K891041](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K891041.md) | MIYA SPECULUM | Zinnanti Surgical Instruments, Inc. | Mar 22, 1989 | SESE | | [K891044](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K891044.md) | LASER SPECULA | Zinnanti Surgical Instruments, Inc. | Mar 17, 1989 | SESE | | [K890375](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K890375.md) | VAGINAL SPECULUM | Kinetic Medical Products | Feb 13, 1989 | SESE | | [K862478](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K862478.md) | HAYES VAGINAL SHIELD | Franklin Medical USA, Inc. | Nov 24, 1986 | SESE | | [K853640](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K853640.md) | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL | Downs Surgical , Ltd. | Oct 29, 1985 | SESE | | [K851799](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K851799.md) | 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA | Artiberia | May 22, 1985 | SESE | | [K843388](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K843388.md) | WELLINGTON HOSPITAL PATTERN SELF-RETAIN | Downs Surgical , Ltd. | Oct 1, 1984 | SESE | | [K821297](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K821297.md) | GRAVES SPECULA | Conphar, Inc. | May 24, 1982 | SESE | | [K821291](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF/K821291.md) | PEDERSON VAGINAL SPECULA | Conphar, Inc. | May 24, 1982 | SESE | ## Top Applicants - Zinnanti Surgical Instruments, Inc. — 2 clearances - Downs Surgical , Ltd. — 2 clearances - Conphar, Inc. — 2 clearances - Thomasville Medical Assoc. — 1 clearance - Kinetic Medical Products — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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