LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER— 510(k) K092879
Substantially EquivalentValleylab
FDA 510(k) clearance K092879 for LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER, Substantially Equivalent on 2009-10-16. Applicant: Valleylab. Device class: 2.
Clearance details
- Applicant
- Valleylab
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boulder, CO, US
Recent devices under product code GEI
view allMore clearances from Valleylab
view all- K063195 — LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044
- K053535 — VIVAWAVE MICROWAVE ABLATION SYSTEM
- K053290 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
- K052796 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
- K051644 — VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.