LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER
FDA 510(k) clearance K092879 · decided 2009-10-16
Clearance details
- K-number
- K092879
- Device name
- LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER
- Applicant
- Valleylab
- Decision
- Substantially Equivalent
- Date received
- 2009-09-18
- Decision date
- 2009-10-16
- Days to decision
- 28 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Valleylab
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile recall (Z-0954-2011) | Covidien LP | 2011-01-25 |