510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160037Unknown

dermaPACE System

Sanuwave, Inc., Alpharetta GA / Direct, Unknown
FDA source (opens on fda.gov)

DEN160037 is the FDA 510(k) clearance record for dermaPACE System, a class II device, cleared for Sanuwave, Inc. on under FDA product code PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers). FDA's definition for product code PZL reads: "Treatment of diabetic foot ulcers". FDA records list one 510(k) clearance for Sanuwave, Inc. As of , FDA records show no recalls naming DEN160037.

Clearance record

Decision date
Received
(521 days to decision)
Product code
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Regulation
21 CFR 878.4685
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sanuwave, Inc. 11475 Great Oaks Way, Suite 150, Alpharetta GA
Third party review
No

Clearances, product code PZL

Trailing 12 months

FDA records hold no clearances under product code PZL in the trailing twelve months.

FDA records show no clearances under product code PZL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260