Signia Small Diameter Reloads
FDA 510(k) clearance K191070 · decided 2019-09-04
Clearance details
- K-number
- K191070
- Device name
- Signia Small Diameter Reloads
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2019-04-22
- Decision date
- 2019-09-04
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Haven, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: S recall (Z-0485-2026) | Covidien, LP | 2025-11-07 |
| Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LO recall (Z-0486-2026) | Covidien, LP | 2025-11-07 |
| Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT recall (Z-1457-2024) | Covidien, LP | 2024-04-01 |
| Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT recall (Z-1458-2024) | Covidien, LP | 2024-04-01 |
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 |