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Trokamed GmbH

FDA Regulatory Profile

Summary

Total Recalls
4 (4 Class I)
510(k) Clearances
4
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0715-2025Class ISheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.November 27, 2024
Z-0713-2025Class ISheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.November 27, 2024
Z-0714-2025Class ISheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.November 27, 2024
Z-0716-2025Class ISheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.November 27, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K200770Mini PCNL-SystemJuly 30, 2021
K091010TROKAMED MORCELLATORMarch 1, 2011
K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESJuly 19, 2006
K060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIESJuly 12, 2006