Home › Device types › FFK
Lithotriptor, Electro-Hydraulic
FDA product code FFK · Class 2 · Gastroenterology, Urology
292
Registered devices
438
Adverse events
21
Recalls
61
510(k) clearances
Devices with this code
LithoClast — E.M.S. Electro Medical Systems S.A.Lithotripsy Probe 1.9FR 250cm French — NORTHGATE TECHNOLOGIES INC.UreTron Cleaning Rod — Ultratellege USA Co., Ltd.StoneBreaker — COOK INCORPORATEDn.a. — Karl Storz GmbH & Co. KGCalcusplit — Karl Storz GmbH & Co. KGCalcusplit — Karl Storz GmbH & Co. KGGyrus ACMI — Gyrus ACMI, LLCEHL-Probe — Walz Elektronik GmbHEHL-Probe — Walz Elektronik GmbHUS-LITHO — Richard Wolf GmbHLITHOCLAST — E.M.S. Electro Medical Systems S.A.LITHOCLAST — E.M.S. Electro Medical Systems S.A.Autolith Touch — NORTHGATE TECHNOLOGIES INC.RIWOLITH — Richard Wolf GmbHLITHOCLAST — E.M.S. Electro Medical Systems S.A.CyberWand USL NoseCone Kit — CYBERSONICS INCAutolith Touch — NORTHGATE TECHNOLOGIES INC.Rigid Pneumatic Probe — BOSTON SCIENTIFIC CORPORATIONRIWOLITH — Richard Wolf GmbHLITHOCLAST — E.M.S. Electro Medical Systems S.A.LITHOCLAST — E.M.S. Electro Medical Systems S.A.UreTron Rigid Hand Piece — Ultratellege USA Co., Ltd.UreTron Flexible Sterile Probe — Ultratellege USA Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-13 | Northgate Technologies, Inc. | Product labeled incorrectly. |
| 2021-10-25 | Northgate Technologies, Inc. | The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. |
| 2020-03-10 | Northgate Technologies, Inc. | As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| 2020-03-10 | Northgate Technologies, Inc. | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| 2020-03-10 | Northgate Technologies, Inc. | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| 2018-01-31 | Cook Inc. | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions |
| 2018-01-31 | Cook Inc. | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions |
| 2018-01-31 | Cook Inc. | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions |
| 2018-01-31 | Cook Inc. | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions |
| 2018-01-31 | Cook Inc. | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions |
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