FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTSTITCH PERFECTPASSER SYSTEM
K Number: K123268
·
Decision Nov 7, 2012
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
6
Review Days
19
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Basic Information
- Device Name
- SMARTSTITCH PERFECTPASSER SYSTEM
- K Number
- K123268
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthocare Corporation
- Date Received
- October 19, 2012
- Decision Date
- November 7, 2012
- Product Code
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Arthocare Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K153669 | MultiFIX S Ultra Knotless Fixation System | Jan 19, 2016 | Substantially Equivalent |
| K131182 | MULTIFIX S KNOTLESS FIXATION DEVICE | Jul 29, 2013 | Substantially Equivalent |
| K120791 | AMBIENT TURBOFLASH 90 IFS | Dec 11, 2012 | Substantially Equivalent |
| K121306 | SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE | Jul 12, 2012 | Substantially Equivalent |
| K013334 | ENDOFLIP | Dec 13, 2001 | Substantially Equivalent |