MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
FDA 510(k) clearance K013274 · decided 2001-11-16
Clearance details
- K-number
- K013274
- Device name
- MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
- Applicant
- Cp Medical
- Decision
- Substantially Equivalent
- Date received
- 2001-10-01
- Decision date
- 2001-11-16
- Days to decision
- 46 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
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product is a synthetic absorbable suture with needle and labeled as sterile. The product i recall (Z-0259-2012) | C P Medical Inc. | 2011-11-19 |
| Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Syn recall (Z-2582-2010) | C P Medical | 2010-09-27 |
| Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical recall (Z-0809-2007) | C P Medical | 2007-05-24 |