Tourniquet Kit
The Tourniquet Kit is a convenience kit assembling components used to apply a tourniquet to a limb for surgical hemostasis or emergency bleeding control. Classified as FDA Class 1 under regulation 21 CFR 878.5900 within the General, Plastic Surgery medical specialty, it is subject to general controls only and falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, requiring no 510(k) submission when all criteria are met. The product code is OJS. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OJS
- Device Class
- FDA class 1
- Regulation Number
- 878.5900
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- 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 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.