MONO-SWIFT
FDA 510(k) clearance K030786 · decided 2003-05-06
Clearance details
- K-number
- K030786
- Device name
- MONO-SWIFT
- Applicant
- Cp Medical
- Decision
- Substantially Equivalent
- Date received
- 2003-03-12
- Decision date
- 2003-05-06
- Days to decision
- 55 days
- Clearance type
- Abbreviated
- 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 |
|---|---|---|
| Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 recall (Z-1708-2014) | C P Medical Inc. | 2014-06-03 |