Media, Reproductive, Exempt
Media, Reproductive, Exempt is a Class 2 obstetrics and gynecology device that is the 510(k)-exempt counterpart of product code MQL, exempted under the 21st Century Cures Act, meaning it does not require premarket notification to market provided it does not exceed the general limitations of exemption under 21 CFR 884.9. It is regulated under 21 CFR 884.6180 within the Obstetrics/Gynecology medical specialty. The product code is QKI. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QKI
- Device Class
- FDA class 2
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
This product code is the class II exempt counterpart of MQL, 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 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.