Delta III Pro— 510(k) K221903
Substantially EquivalentDornier Medtech America, Inc.
FDA 510(k) clearance K221903 for Delta III Pro, Substantially Equivalent on 2023-02-22. Applicant: Dornier Medtech America, Inc.. Device class: 2.
Clearance details
- Applicant
- Dornier Medtech America, Inc.
- 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
view allMore clearances from Dornier Medtech America, Inc.
view allAdverse 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.