inforMED
OFTClass II

Spinal Epidural Anesthesia Kit

Anesthesiology · 21 CFR 868.5120

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.

MDR events286All time
Recalls37All time
Registered firms24Currently listed
510(k) clearances0All time

Recalls

37 recall events for this product code

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510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.