MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
FDA 510(k) clearance K003914 · decided 2001-02-22
Clearance details
- K-number
- K003914
- Device name
- MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
- Applicant
- Medtronic PS Medical
- Decision
- Substantially Equivalent
- Date received
- 2000-12-19
- Decision date
- 2001-02-22
- Days to decision
- 65 days
- Clearance type
- Abbreviated
- Product code
- GWG
- Device class
- 2
- Regulation number
- 882.1480
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.