Gynecological Laparoscopic Kit
The Gynecological Laparoscopic Kit is a convenience kit containing instruments and components assembled for use in gynecological laparoscopic procedures, such as diagnostic laparoscopy, tubal ligation, or laparoscopic treatment of endometriosis. Classified as FDA Class 2 under regulation 21 CFR 884.1720 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 OHD. It is not flagged as an implant or life-sustaining device.
Research product code OHD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OHD
- Device Class
- FDA class 2
- Regulation Number
- 884.1720
- 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 27 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.