Endometrial Sampling Kit
The Endometrial Sampling Kit (product code OKZ) is a Class 2 convenience kit regulated under 21 CFR 884.1175 in the Obstetrics/Gynecology specialty (OB), designed to facilitate endometrial tissue sampling. Per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this kit is under enforcement discretion and does not require a 510(k) premarket notification if all guidance criteria are met. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OKZ
- Device Class
- FDA class 2
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.