FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
COMPRESSION ANASTOMOSIS CLIP (CAC)
K Number: K033324
·
Decision May 10, 2004
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
6
Review Days
208
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Basic Information
- Device Name
- COMPRESSION ANASTOMOSIS CLIP (CAC)
- K Number
- K033324
- 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
- Niti Medical Technologies , Ltd.
- Date Received
- October 15, 2003
- Decision Date
- May 10, 2004
- 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 Niti Medical Technologies , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K062008 | ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR) | Aug 9, 2006 | Substantially Equivalent |
| K050356 | COMPRESSION ANASTOMOSIS RING (CAR) | May 5, 2005 | Substantially Equivalent |
| K043115 | LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) | Dec 1, 2004 | Substantially Equivalent |
| K042492 | HAND STC, MODEL 60MM | Oct 19, 2004 | Substantially Equivalent |
| K041751 | COMPRESSION ANASTOMOSIS CLIP (CAC) | Sep 16, 2004 | Substantially Equivalent |