Valleylab FT10 Electrosurgical Platform
FDA 510(k) clearance K191601 · decided 2019-07-12
Clearance details
- K-number
- K191601
- Device name
- Valleylab FT10 Electrosurgical Platform
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2019-06-17
- Decision date
- 2019-07-12
- Days to decision
- 25 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GEN recall (Z-0631-2024) | Covidien | 2024-01-03 |
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 |