Spinal Anesthesia Kit
FDA product code OFU · Class II (moderate risk) · 21 CFR 868.5120 · Anesthesiology
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.
0510(k) clearances
0PMA approvals
3recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2278-2026 Class I | Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description…These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the… | B Braun Medical Inc | 05/06/2026Open, Classified |
| Z-2277-2026 Class I | Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan…These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the… | B Braun Medical Inc | 05/06/2026Open, Classified |
| Z-2276-2026 Class I | Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL…These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the… | B Braun Medical Inc | 05/06/2026Open, Classified |