FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
K Number: K982837
·
Decision Nov 6, 1998
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
35
Review Days
86
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Basic Information
- Device Name
- KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
- K Number
- K982837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz Endoscopy
- Date Received
- August 12, 1998
- Decision Date
- November 6, 1998
- Product Code
- GWG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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|---|---|---|---|
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| K023924 | AUTOCON II 200 ELECTROSURGICAL GENERATOR | Feb 21, 2003 | Substantially Equivalent |
| K023187 | KSEA SPINOSCOPE | Dec 2, 2002 | Substantially Equivalent |
| K011700 | MODULITH SLK LITHOTRIPTER | Aug 16, 2002 | Substantially Equivalent |
| K021776 | KSEA QUADRO SWITCH | Aug 15, 2002 | Substantially Equivalent |
| K013107 | BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | Feb 26, 2002 | Substantially Equivalent |
| K011841 | KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR | Sep 10, 2001 | Substantially Equivalent |
| K010569 | KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP | Apr 9, 2001 | Substantially Equivalent |