U.S. FDA Medical Device Vaginal Applicator Requirements
FDA Medical Device Definition: 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.
FDA Vaginal Applicator Label Requirements and Exceptions
FDA Vaginal Applicator Import Information
FDA Vaginal Applicator Detentions (Vaginal Applicator Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Vaginal Applicator Manufacturers (Vaginal Applicator Suppliers)
- Vaginal Applicator Distributors
- Vaginal Applicator Processors
- Vaginal Applicator Repackers
- Vaginal Applicator Relabelers
- Vaginal Applicator Exporters
- Vaginal Applicator Importers
For more information about Vaginal Applicator Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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