FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
COROLENE
K Number: K052701
·
Decision Dec 13, 2005
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
7
Review Days
76
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Basic Information
- Device Name
- COROLENE
- K Number
- K052701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peters Surgical
- Date Received
- September 28, 2005
- Decision Date
- December 13, 2005
- Product Code
- GAW
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Peters Surgical
| K Number | Device Name | ||
|---|---|---|---|
| K233265 | Monotime and Optime R | Oct 11, 2024 | Substantially Equivalent |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Jul 12, 2024 | Substantially Equivalent |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | Aug 3, 2007 | Substantially Equivalent |
| K060465 | PREMIO | Jan 17, 2007 | Substantially Equivalent |
| K060163 | CARDIOFLON, CARDIOXYL | Oct 11, 2006 | Substantially Equivalent |
| K062366 | OPTIME, SINUSORB PGA | Oct 2, 2006 | Substantially Equivalent |