FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FINE-JECT
K Number: K983067
·
Decision Oct 30, 1998
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
9
Review Days
58
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Basic Information
- Device Name
- FINE-JECT
- K Number
- K983067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Henke Sass Wolf of America, Inc.
- Date Received
- September 2, 1998
- Decision Date
- October 30, 1998
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Henke Sass Wolf of America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | Mar 18, 2008 | Substantially Equivalent |
| K050163 | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE | Mar 24, 2005 | Substantially Equivalent |
| K030572 | HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE | Apr 1, 2003 | Substantially Equivalent |
| K013611 | HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE | Feb 1, 2002 | Substantially Equivalent |
| K991563 | CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C | Oct 13, 1999 | Substantially Equivalent |
| K981751 | SINUSCOPE AND ACCESSORIES | Aug 13, 1998 | Substantially Equivalent |
| K962075 | HSW GMBH ARTHROSCOPE | Jan 17, 1997 | Substantially Equivalent |
| K941541 | HSV LAPAROSCOPY SET | May 16, 1994 | Substantially Equivalent |