MLT

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Pelvic Exam 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

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