FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLANTABLE CLIP
K Number: K100090
·
Decision Feb 2, 2010
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
5
Review Days
21
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Basic Information
- Device Name
- IMPLANTABLE CLIP
- K Number
- K100090
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genicon
- Date Received
- January 12, 2010
- Decision Date
- February 2, 2010
- 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 Genicon
| K Number | Device Name | ||
|---|---|---|---|
| K132375 | GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG | Jun 12, 2014 | Substantially Equivalent |
| K061417 | GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 | Oct 10, 2006 | Substantially Equivalent |
| K041967 | GENICON SUCTION IRRIGATION SYSTEM | Nov 12, 2004 | Substantially Equivalent |
| K041968 | GENICON BIPOLAR FORCEPS MODEL # 600-005-005 | Nov 3, 2004 | Substantially Equivalent |