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U.S. FDA Medical Device Uterine Clamp Requirements

FDA Medical Device Definition: Uterine_Clamp=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 following1) 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

Registrar Corp assists Uterine Clamp companies with:

  • FDA Uterine Clamp Establishment Registration
  • FDA Uterine Clamp Listing
  • FDA Uterine Clamp Label Requirements and Exceptions
  • FDA Uterine Clamp Import Information
  • FDA Uterine Clamp Detentions (Uterine Clamp Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Uterine Clamp Manufacturers (Uterine Clamp Suppliers)
       - Uterine Clamp Distributors
       - Uterine Clamp Processors
       - Uterine Clamp Repackers
       - Uterine Clamp Relabelers
       - Uterine Clamp Exporters
       - Uterine Clamp Importers
For more information about Uterine Clamp 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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