MLS

6 FDA 510(k) clearances · Product code

FDA profile

Official device name

Labor And Delivery Kit

Device class

Class II (moderate risk)

Regulation

21 CFR 884.4530

Medical specialty

Obstetrics/Gynecology

FDA 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

Adverse events (MAUDE)

1997: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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