MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
FDA 510(k) clearance K030212 · decided 2003-03-27
Clearance details
- K-number
- K030212
- Device name
- MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
- Applicant
- Genzyme Biosurgery
- Decision
- Substantially Equivalent
- Date received
- 2003-01-21
- Decision date
- 2003-03-27
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- NEW
- Device class
- 2
- Regulation number
- 878.4840
- 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 |
|---|---|---|
| CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbabl recall (Z-1534-2014) | Teleflex Medical | 2014-05-01 |
| Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 recall (Z-1509-2014) | Teleflex Medical | 2014-04-25 |
| Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical recall (Z-1016-2007) | Teleflex Creek Dr | 2007-07-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PREVELLE SILK (P030032/S017) | Genzyme Biosurgery | 2014-09-05 |
| PREVELLE SILK (P030032/S016) | Genzyme Biosurgery | 2014-08-06 |
| PREVELLE SILK (P030032/S014) | Genzyme Biosurgery | 2012-05-03 |
| PREVELLE SILK (P030032/S013) | Genzyme Biosurgery | 2011-10-07 |
| HYLAFORM (HYLAN B GEL); PREVELLE SILK (P030032/S012) | Genzyme Biosurgery | 2011-07-18 |
| PREVELLE SILK (P030032/S010) | Genzyme Biosurgery | 2010-09-15 |
| HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL) (P030032/S008) | Genzyme Biosurgery | 2010-02-24 |
| PREVELLE SILK & HYLAN B GEL (P030032/S009) | Genzyme Biosurgery | 2009-10-09 |