FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
K Number: K991563
·
Decision Oct 13, 1999
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
9
Review Days
161
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Basic Information
- Device Name
- CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
- K Number
- K991563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Henke Sass Wolf of America, Inc.
- Date Received
- May 5, 1999
- Decision Date
- October 13, 1999
- Product Code
- HIH
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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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 |
| K983067 | FINE-JECT | Oct 30, 1998 | 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 |