FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COALESCENT SURGICAL U-CLIP
K Number: K012317
·
Decision Aug 31, 2001
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
9
Review Days
39
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Basic Information
- Device Name
- COALESCENT SURGICAL U-CLIP
- K Number
- K012317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coalescent Surgical
- Date Received
- July 23, 2001
- Decision Date
- August 31, 2001
- Product Code
- FZP
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Coalescent Surgical
| K Number | Device Name | ||
|---|---|---|---|
| K040821 | COALESCENT SURGICAL U-CLIP AND ACCESSORIES | Apr 23, 2004 | Substantially Equivalent |
| K031623 | MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES | Jul 3, 2003 | Substantially Equivalent |
| K024366 | COALESCENT SURGICAL U-CLIP AND ACCESSORIES | Jan 17, 2003 | Substantially Equivalent |
| K023125 | COALESCENT U-CLIP- AND ACCESSORIES | Dec 18, 2002 | Substantially Equivalent |
| K021407 | COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES | Jul 3, 2002 | Substantially Equivalent |
| K013664 | COALESCENT SURGICAL U-CLIP | Jan 24, 2002 | Substantially Equivalent |
| K003958 | COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE | Feb 6, 2001 | Substantially Equivalent |
| K994160 | COALESCENT SURGICAL SUTURED-CLIP | Feb 4, 2000 | Substantially Equivalent |