VISU-LOCK 5MM CLIP APPLIER
FDA 510(k) clearance K033161 · decided 2003-12-18
Clearance details
- K-number
- K033161
- Device name
- VISU-LOCK 5MM CLIP APPLIER
- Applicant
- Gyrx, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-09-30
- Decision date
- 2003-12-18
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.