LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED
FDA 510(k) clearance K141153 · decided 2014-08-14
Clearance details
- K-number
- K141153
- Device name
- LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2014-05-05
- Decision date
- 2014-08-14
- Days to decision
- 101 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
+ Add to Predicate Builder ◉ Watch Covidien
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006) | Covidien | 1997-06-24 |
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005) | Covidien | 1995-12-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004) | Covidien | 1995-06-14 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003) | Covidien | 1994-06-17 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002) | Covidien | 1994-03-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001) | Covidien | 1993-09-10 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034) | Covidien | 1991-12-13 |