||tubing and tubing/filter fits|
||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.
||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.
||tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access
||distend the uterine cavity
|Regulation Medical Specialty
Office of Device Evaluation
Division of Reproductive, Gastro-Renal, and Urological Devices
Obstetrics and Gynecology Devices Branch (OGDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
| 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