Hysteroscope Accessories
The Hysteroscope Accessories (product code NWW) are non-powered, non-inflatable manual mechanical devices such as cannulas, graspers, forceps, dissectors, and scissors, used in conjunction with hysteroscopes for diagnostic and surgical procedures within the cervical canal and uterine cavity. Classified as FDA Class 1 and exempt from 510(k) requirements, it is regulated under 21 CFR 884.1690 within the Obstetrics/Gynecology specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NWW
- Device Class
- FDA class 1
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.