COOK HOLMIUM LASER FIBER— 510(k) K124030
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K124030 for COOK HOLMIUM LASER FIBER, Substantially Equivalent on 2013-07-01. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- 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
- Special
- Location
- Bloomington, IN, US
Recent devices under product code GEX
view allMore clearances from Cook Incorporated
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 K124030
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 K124030.
Data sourced from openFDA. This site is unofficial and independent of the FDA.