510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191961Substantially Equivalent

OrthoGold

Tissue Regeneration Technologies, Woodstock GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191961 is the FDA 510(k) clearance record for OrthoGold, a class II device, cleared for Tissue Regeneration Technologies 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 5 510(k) clearances for Tissue Regeneration Technologies, from to . As of , FDA records show no recalls naming K191961.

Clearance record

Decision date
Received
(126 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
Tissue Regeneration Technologies 251 Heritage Walk, Woodstock GA
510(k) summary
Summary PDF
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