Mini PCNL-System— 510(k) K200770
Substantially EquivalentTrokamed GmbH
FDA 510(k) clearance K200770 for Mini PCNL-System, Substantially Equivalent on 2021-07-30. Applicant: Trokamed GmbH. Device class: 2.
Clearance details
- Applicant
- Trokamed GmbH
- Product code
- Code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geisingen, DE
Recent devices under product code FED
view allMore clearances from Trokamed GmbH
view allAdverse events under product code FED
product code FED- Death
- 10
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200770
K-number listed on FDA's recall record- Z-0713-2025 — Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
- Z-0714-2025 — Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
- Z-0715-2025 — Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
- Z-0716-2025 — Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200770.
Data sourced from openFDA. This site is unofficial and independent of the FDA.