Colposcope (And Colpomicroscope), Exempt
The Colposcope (And Colpomicroscope) (Exempt) is an obstetrics/gynecology device used to magnify and illuminate the cervix, vagina, and vulva for detailed examination, typically to evaluate abnormal Pap smear results or to identify cervical lesions. Product code PTZ is the Class II exempt counterpart of HEX, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 884.9. Under regulation 21 CFR 884.1630, it is a Class II device subject to general and special controls. It falls under the Obstetrics/Gynecology medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PTZ
- Device Class
- FDA class 2
- Regulation Number
- 884.1630
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
This product code is the class II exempt counterpart of HEX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.