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NWWClass I

Hysteroscope Accessories

21 CFR 884.1690 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

NWW is the FDA product code for Hysteroscope Accessories, a class I device type, regulated under 21 CFR 884.1690. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NWW
Device name
Hysteroscope Accessories
FDA 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.
Regulation
21 CFR 884.1690
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order