FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K Number: K130078
·
Decision Feb 28, 2013
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
7
Review Days
45
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Basic Information
- Device Name
- QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K Number
- K130078
- 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
- Surgical Specialties Corp. Dba Angiotech
- Date Received
- January 14, 2013
- Decision Date
- February 28, 2013
- 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 |
Similar 510(k) Clearances
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Other Clearances by Surgical Specialties Corp. Dba Angiotech
| K Number | Device Name | ||
|---|---|---|---|
| K133420 | TRANQUILL BARBED DEVICE | Nov 29, 2013 | Substantially Equivalent |
| K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE | May 16, 2013 | Substantially Equivalent |
| K123877 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Jan 2, 2013 | Substantially Equivalent |
| K123836 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Dec 21, 2012 | Substantially Equivalent |
| K123409 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Nov 20, 2012 | Substantially Equivalent |
| K122898 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Oct 22, 2012 | Substantially Equivalent |