ESSEX ENDOSCOPE, MODEL SXD-1000
FDA 510(k) clearance K023627 · decided 2002-11-12
Clearance details
- K-number
- K023627
- Device name
- ESSEX ENDOSCOPE, MODEL SXD-1000
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-28
- Decision date
- 2002-11-12
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Clara, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.