DeviceClearance

Product code MLT— Obstetrics/Gynecology

CARAPACE PELVIC EXAM TRAYS

Classification name
Pelvic Exam Kit
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code MLT under 21 CFR 884.4530, via openFDA

Market context for product code MLT

FDA has cleared 1 device under product code MLT, all in 1994, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code MLT

Recent clearances under product code MLT

Data sourced from openFDA. This site is unofficial and independent of the FDA.