MLT

Pelvic Exam Kit

Product code

MLT

Device name

Pelvic Exam Kit

Device class

Class 2

21 CFR

21 CFR 884.4530

Medical specialty

Obstetrics/Gynecology

Marketing pathway

Enforcement Discretion

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).