LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
FDA 510(k) clearance K031011 · decided 2003-05-29
Clearance details
- K-number
- K031011
- Device name
- LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
- Applicant
- Valleylab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-31
- Decision date
- 2003-05-29
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufac recall (Z-0640-2012) | Covidien, PLC | 2012-01-11 |
| LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured fo recall (Z-0641-2012) | Covidien, PLC | 2012-01-11 |