inforMED
OFUClass II

Spinal 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 events142All time
Recalls3All time
Registered firms17Currently listed
510(k) clearances0All time

Recent MDR events

142 adverse event reports on file

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Event type breakdown

Malfunction113
Injury27
Other2

Most-reported manufacturers

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B. Braun Medical Inc.111Unspecified11B Braun Melsungen Ag4Smiths Medical Asd, Inc.4Arrow International, Inc. (subsidiary Of Teleflex, Inc.)1B . Braun Medical Inc.1B Braun / B. Braun Medical Inc.1B Braun Medical Inc1

Recalls

3 recall events for this product code

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Registered firms

17 firms currently registered 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.