Delta III Lithotripter— 510(k) K170122
Substantially EquivalentDornier Medtech America
FDA 510(k) clearance K170122 for Delta III Lithotripter, Substantially Equivalent on 2017-06-28. Applicant: Dornier Medtech America. Device class: 2.
Clearance details
- Applicant
- Dornier Medtech America
- Product code
- Code LNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.5990
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kennesaw, GA, US
Recent devices under product code LNS
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view all- K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250
- K233380 — TRIDENT Mobile Fluoroscopy System
- K180350 — Dornier Medilas H Solvo 35 Laser
- K151298 — Gemini XXP-HP
- K132672 — EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
Adverse events under product code LNS
product code LNS- Death
- 4
- Injury
- 320
- Total
- 324
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.