Culdocentesis Kit
The Culdocentesis Kit is a convenience kit containing components used to perform culdocentesis, a procedure in which a needle is inserted through the posterior vaginal wall into the cul-de-sac to aspirate fluid, used diagnostically for suspected ectopic pregnancy or pelvic infection. Classified as FDA Class 2 under regulation 21 CFR 884.1640 within the Obstetrics/Gynecology medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are satisfied. The product code is OHF. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OHF
- Device Class
- FDA class 2
- Regulation Number
- 884.1640
- 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.