DeviceClearance

Product code PWI— Obstetrics/Gynecology

Capio SLIM Suture Capturing Device

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

FDA classification definition

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

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

Market context for product code PWI

FDA has cleared 2 devices under product code PWI between 2017 and 2018, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code PWI

Recent clearances under product code PWI

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