FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENICON CLIP APPLIER
K Number: K030269
·
Decision Mar 20, 2003
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
6
Review Days
52
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Basic Information
- Device Name
- GENICON CLIP APPLIER
- K Number
- K030269
- 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
- Genicon, LC
- Date Received
- January 27, 2003
- Decision Date
- March 20, 2003
- 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, LC
| K Number | Device Name | ||
|---|---|---|---|
| K030174 | GENICON LAPAROSCOPES | Jun 19, 2003 | Substantially Equivalent |
| K002542 | REUSABLE CANNULA | Oct 23, 2000 | Substantially Equivalent |
| K993625 | INSUFFLATION NEEDLE- 120MM, MODEL 900-200 | Jun 20, 2000 | Substantially Equivalent |
| K991382 | SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 | Jul 15, 1999 | Substantially Equivalent |
| K982472 | GENICON TROCAR | Feb 4, 1999 | Substantially Equivalent |