FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K Number: K062244
·
Decision Oct 2, 2006
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
112
Review Days
60
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Basic Information
- Device Name
- OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
- K Number
- K062244
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrocare Corp.
- Date Received
- August 3, 2006
- Decision Date
- October 2, 2006
- Product Code
- OCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
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