Spinal Anesthesia Kit
The Spinal Anesthesia Kit is a convenience kit containing the components required to perform spinal (intrathecal) anesthesia, a common procedure for surgical and obstetric pain relief. It is classified as FDA Class 2, which typically requires a 510(k) premarket notification; however, under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, this kit is under enforcement discretion and does not require a 510(k) submission if it meets all applicable criteria. The product code is OFU, regulated under 21 CFR 868.5120, within the Anesthesiology medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OFU
- 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 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.