EXCISOR BIOPTOME, MODEL 01-0004
FDA 510(k) clearance K032847 · decided 2003-09-26
Clearance details
- K-number
- K032847
- Device name
- EXCISOR BIOPTOME, MODEL 01-0004
- Applicant
- Acueity, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-12
- Decision date
- 2003-09-26
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Palo Alto, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.