DeviceClearance

Product code PWK— Obstetrics/Gynecology

Meridian Vaginal Positioning System (VPS)

Classification name
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
Device class
Class 2
Regulation
21 CFR 884.4910
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair”

— U.S. Food and Drug Administration, device classification record for product code PWK under 21 CFR 884.4910, via openFDA

Market context for product code PWK

FDA has cleared 1 device under product code PWK, all in 2018, 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 PWK

Recent clearances under product code PWK

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