FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KSEA QUADRO SWITCH
K Number: K021776
·
Decision Aug 15, 2002
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
35
Review Days
78
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Basic Information
- Device Name
- KSEA QUADRO SWITCH
- K Number
- K021776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz Endoscopy
- Date Received
- May 29, 2002
- Decision Date
- August 15, 2002
- Product Code
- OCX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Karl Storz Endoscopy
| K Number | Device Name | ||
|---|---|---|---|
| K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES | Jan 24, 2005 | Substantially Equivalent |
| K030848 | PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | Jun 2, 2003 | Substantially Equivalent |
| K030009 | KSEA POWERSHAVER SYSTEM S2 | Apr 2, 2003 | Substantially Equivalent |
| 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 |
| 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 |
| K004037 | X-RAY SYSTEM XR-MX | Feb 2, 2001 | Substantially Equivalent |