FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONO-SWIFT
K Number: K030786
·
Decision May 6, 2003
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
63
Applicant Total
31
Review Days
55
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Basic Information
- Device Name
- MONO-SWIFT
- K Number
- K030786
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4840
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cp Medical
- Date Received
- March 12, 2003
- Decision Date
- May 6, 2003
- Product Code
- NEW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEW | Suture, Surgical, Absorbable, Polydioxanone | FDA class 2 | General, Plastic Surgery |
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FDA 510(k)
FDA Class 2
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Other Clearances by Cp Medical
| K Number | Device Name | ||
|---|---|---|---|
| K094028 | CP-FIBER (ORTHOFIBER) | Mar 18, 2010 | Substantially Equivalent |
| K072229 | MONOSWIFT | Oct 5, 2007 | Substantially Equivalent |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | Jul 18, 2007 | Substantially Equivalent |
| K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | Nov 2, 2006 | Substantially Equivalent |
| K041894 | ORTHOFIBER | Sep 17, 2004 | Substantially Equivalent |
| K034062 | CP SLEEVE AND RIVER SLEEVE | Jan 30, 2004 | Substantially Equivalent |
| K024372 | CP MEDICAL BONE WAX | Jun 19, 2003 | Substantially Equivalent |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Mar 28, 2003 | Substantially Equivalent |
| K023710 | VISORB SWIFT | Jan 17, 2003 | Substantially Equivalent |
| K022075 | DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 | Sep 19, 2002 | Substantially Equivalent |