ARCHIMEDES Biodegradable Pancreatic Stent— 510(k) K243412
Substantially EquivalentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
FDA 510(k) clearance K243412 for ARCHIMEDES Biodegradable Pancreatic Stent, Substantially Equivalent on 2025-07-16. Applicant: Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.).
Clearance details
- Applicant
- Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
- Product code
- Code FGE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlotte, NC, US
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.