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. Device class: 2.
Clearance details
- Applicant
- Ipg Medical Corporation
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code GEX
view allMore clearances from Ipg Medical Corporation
view allAdverse 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 →
Recalls naming K232568
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232568.
Data sourced from openFDA. This site is unofficial and independent of the FDA.