KSEA QUADRO SWITCH
FDA 510(k) clearance K021776 · decided 2002-08-15
Clearance details
- K-number
- K021776
- Device name
- KSEA QUADRO SWITCH
- Applicant
- Karl Storz Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2002-05-29
- Decision date
- 2002-08-15
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.