ClearanceBrief
Company ยท DE

Trokamed GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2021. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
FEDEndoscopic Access Overtube, Gastroenterology-Urology5
GCJLaparoscope, General & Plastic Surgery1
GEIElectrosurgical, Cutting & Coagulation & Accessories1
HETLaparoscope, Gynecologic (And Accessories)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 30, 2021K200770Mini PCNL-System
Trokamed GmbH, DE
FED
Mar 1, 2011K091010TROKAMED MORCELLATOR
Trokamed GmbH, NL
HET
Jul 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
Trokamed GmbH, DE
GCJ
Jul 12, 2006K060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
Trokamed GmbH, DE
GEI

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 10, 2025Trokamed GmbH
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Open, Classified		 FEDK200770
Jan 10, 2025Trokamed GmbH
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Open, Classified		 FEDK200770
Jan 10, 2025Trokamed GmbH
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Open, Classified		 FEDK200770
Jan 10, 2025Trokamed GmbH
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Open, Classified		 FEDK200770
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