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510(k) K191961

OrthoGold by Tissue Regeneration Technologies — Product Code PZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2019
Date Received
July 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class
Class II
Regulation Number
878.4685
Review Panel
SU
Submission Type

Treatment of diabetic foot ulcers

Other clearances by Tissue Regeneration Technologies

  • K210451 — OrthoGold 100 (May 5, 2021)
  • K200926 — OrthoGold 100 (August 28, 2020)
  • K182682 — OrthoGold 100 (December 21, 2018)
  • K062081 — LITHOGOLD (November 2, 2006)

Other clearances for product code PZL

  • K243279 — DOLORCLAST Focused Shock Waves (August 13, 2025)
  • K250779 — CS-Pro MED (July 2, 2025)
  • K233937 — OW100S (July 9, 2024)
  • K231710 — OW100S (September 1, 2023)
  • K202112 — Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece (February 21, 2021)
  • K200926 — OrthoGold 100 (August 28, 2020)
  • DEN160037 — dermaPACE System (December 28, 2017)