Spinal Epidural Anesthesia Kit
The Spinal Epidural Anesthesia Kit is a convenience kit used to assemble the components needed to administer spinal epidural anesthesia, a technique widely used for surgical and obstetric pain management. It is classified as FDA Class 2, which normally requires a 510(k) premarket notification, but this kit is subject to enforcement discretion under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) submission if it meets all criteria in that guidance. The product code is OFT, regulated under 21 CFR 868.5120, and falls within the Anesthesiology medical specialty. It is not flagged as an implant, life-sustaining, or life-supporting device.
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Basic Information
- Product Code
- OFT
- Device Class
- FDA class 2
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- 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 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.