Dornier Ureteral Stent— 510(k) K190312

Name: FDA 510(k) clearance K190312
Creator: U.S. Food and Drug Administration
Published: 2019-11-15

Substantially Equivalent

Dornier Medtech America, Inc.

FDA 510(k) clearance K190312 for Dornier Ureteral Stent, Substantially Equivalent on 2019-11-15. Applicant: Dornier Medtech America, Inc.. Device class: 2.

Clearance details

Applicant: Dornier Medtech America, Inc.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 2019-02-12
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAD

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K251890 — Disposable Ureteral Stents2026-02-20
K251469 — Endura Ureteral Stent and Stent Set2025-12-19
K243039 — Ureteral Stents (AF-D series)2025-06-18
K243830 — Disposable ureteral stent2025-05-14
K250824 — Percuflex Ureteral Stent +11 more2025-04-15

More clearances from Dornier Medtech America, Inc.

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K221903 — Delta III Pro2023-02-22
K213252 — Dornier Thulio2022-07-27
K220871 — Nautilus2022-04-18
K210394 — Electrosurgical accessory2021-05-19
K201815 — Dornier MAGELLAN Ureteral Access Sheath2020-11-20

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.