IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories— 510(k) K232568
Substantially EquivalentIpg Medical Corporation
FDA 510(k) clearance K232568 for IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories, Substantially Equivalent on 2024-03-21. Applicant: Ipg Medical Corporation.
Clearance details
- Applicant
- Ipg Medical Corporation
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
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.