COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
FDA 510(k) clearance K021019 · decided 2002-06-18
Clearance details
- K-number
- K021019
- Device name
- COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
- Applicant
- Genzyme Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-29
- Decision date
- 2002-06-18
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- GAT
- Device class
- 2
- Regulation number
- 878.5000
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fall River, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorba recall (Z-1291-2014) | Teleflex Medical | 2014-03-26 |
| Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-abs recall (Z-1292-2014) | Teleflex Medical | 2014-03-26 |
| Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-ab recall (Z-1293-2014) | Teleflex Medical | 2014-03-26 |
| Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-ab recall (Z-1294-2014) | Teleflex Medical | 2014-03-26 |
| Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product recall (Z-1295-2014) | Teleflex Medical | 2014-03-26 |
| Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable sil recall (Z-1296-2014) | Teleflex Medical | 2014-03-26 |
| Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN B recall (Z-1017-2007) | Teleflex Creek Dr | 2007-07-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGOO (P110003/S004) | Genzyme Corp. | 2014-03-26 |
| LEGOO (P110003/S003) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUSION GEL (P110003/S002) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUDER (P110003/S001) | Genzyme Corp. | 2012-03-01 |
| LEGOO (P110003) | Genzyme Corp. | 2011-09-28 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S007) | Genzyme Corp. | 2003-12-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S006) | Genzyme Corp. | 2003-02-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S005) | Genzyme Corp. | 2002-11-25 |