DeviceClearance

Product code PZL— General, Plastic Surgery

OW100S

Classification name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device class
Class 2
Regulation
21 CFR 878.4685
Advisory panel
General, Plastic Surgery
Total cleared
8
First cleared
Most recent

FDA classification definition

“Treatment of diabetic foot ulcers”

— U.S. Food and Drug Administration, device classification record for product code PZL under 21 CFR 878.4685, via openFDA

Market context for product code PZL

FDA has cleared 8 devices under product code PZL between 2017 and 2025, filed by 7 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 PZL

Recent clearances under product code PZL

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