AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES
FDA 510(k) clearance K090470 · decided 2009-05-14
Clearance details
- K-number
- K090470
- Device name
- AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2009-02-23
- Decision date
- 2009-05-14
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- OCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- North Haven, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixa recall (Z-0986-2024) | Covidien LP | 2024-02-06 |
| Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopi recall (Z-1157-2010) | Covidien LP | 2010-03-16 |
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 |