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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

Extender Cable, Autolith — NORTHGATE TECHNOLOGIES INC.LITHOCLAST — E.M.S. Electro Medical Systems S.A.RIWOLITH — Richard Wolf GmbHLITHOCLAST — E.M.S. Electro Medical Systems S.A.n.a. — Karl Storz GmbH & Co. KGGyrus ACMI — Gyrus ACMI, LLCEHL-Probe — Walz Elektronik GmbHLITHOCLAST — E.M.S. Electro Medical Systems S.A.UreTron Semi Rigid Sterile Probe 1.5 x 570 mm — Ultratellege USA Co., Ltd.LITHOCLAST — E.M.S. Electro Medical Systems S.A.LITHOCLAST — E.M.S. Electro Medical Systems S.A.LITHOCLAST — E.M.S. Electro Medical Systems S.A.EHL Probe — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.Cyberwand USL Wrench — CYBERSONICS INCUltrasound Probe — BOSTON SCIENTIFIC CORPORATIONUreTron Rigid Sterile Probe 3.5 x 430mm — Ultratellege USA Co., Ltd.LITHOCLAST — E.M.S. Electro Medical Systems S.A.RIWOLITH — Richard Wolf GmbHUltrasound Probe — BOSTON SCIENTIFIC CORPORATIONUreTron Flexible Sterile Probe 0.8 x 600 mm — Ultratellege USA Co., Ltd.Gyrus ACMI — Gyrus ACMI, LLCNA — Richard Wolf GmbHLITHOCLAST — E.M.S. Electro Medical Systems S.A.LITHOCLAST — E.M.S. Electro Medical Systems S.A.

Recent recalls

DateFirmReason
2022-04-13Northgate Technologies, Inc.Product labeled incorrectly.
2021-10-25Northgate Technologies, Inc.The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
2020-03-10Northgate Technologies, Inc.As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10Northgate Technologies, Inc.Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10Northgate Technologies, Inc.Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions
2018-01-31Cook 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.