DAUM BIOPSYNEEDLE
FDA 510(k) clearance K961185 · decided 1996-04-30
Clearance details
- K-number
- K961185
- Device name
- DAUM BIOPSYNEEDLE
- Applicant
- Ferguson Medical
- Decision
- Substantially Equivalent
- Date received
- 1996-03-26
- Decision date
- 1996-04-30
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Chico, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.