Chrysalis Intelligence · Sponsors · Trokamed GmbH

Trokamed GmbH

Geisingen, DE · 1 510(k) clearances · 4 recalls (4 Class I)

Total clearances
1
2021-07-30 → 2021-07-30
Last 12 months
0
Product codes
1
Most recent
2021-07-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FED Endoscopic Access Overtube, Gastroenterology-Urology Class II Gastroenterology, Urology 1 2021-07-30
Safety

Recalls (4)

Class I (serious)
4
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2024-11-27
DateSeverityStatusRecall # ProductCodeReason
2024-11-27 Class I Ongoing Z-0716-2025 Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly bu…
2024-11-27 Class I Ongoing Z-0715-2025 Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly bu…
2024-11-27 Class I Ongoing Z-0714-2025 Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly bu…
2024-11-27 Class I Ongoing Z-0713-2025 Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube. If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly bu…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-07-30 K200770 Mini PCNL-System FED Class II Gastroenterology, Urology