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U.S. Department of Health and Human Services

Product Classification

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Device tubing and tubing/filter fits
Regulation Description Hysteroscopic insufflator.
Definition Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.
Physical State tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation.
Technical Method tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access
Target Area distend the uterine cavity
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeNVT
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(K) Exempt
Regulation Number 884.1700
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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