ENDOSCOPIC NEEDLE DRIVER
FDA 510(k) clearance K960011 · decided 1996-02-21
Clearance details
- K-number
- K960011
- Device name
- ENDOSCOPIC NEEDLE DRIVER
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1996-01-02
- Decision date
- 1996-02-21
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- OCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.