AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
FDA 510(k) clearance K083519 · decided 2009-04-10
Clearance details
- K-number
- K083519
- Device name
- AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
- Applicant
- Covidien Lp, Formerly Registered AS United States
- Decision
- Substantially Equivalent
- Date received
- 2008-11-26
- Decision date
- 2009-04-10
- 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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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 |
|---|---|---|
| INDERMIL TISSUE ADHESIVE (P010002/S004) | Covidien Lp, Formerly Registered AS United States | 2003-11-12 |
| INDERMIL TISSUE ADHESIVE (P010002/S003) | Covidien Lp, Formerly Registered AS United States | 2003-01-31 |
| INDERMIL TISSUE ADHESIVE (P010002/S002) | Covidien Lp, Formerly Registered AS United States | 2002-06-28 |
| INDERMIL TISSUE ADHESIVE (P010002/S001) | Covidien Lp, Formerly Registered AS United States | 2002-06-20 |
| INDERMIL(TM) TISSUE ADHESIVE (P010002) | Covidien Lp, Formerly Registered AS United States | 2002-05-22 |