STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
FDA 510(k) clearance K002547 · decided 2000-10-20
Clearance details
- K-number
- K002547
- Device name
- STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
- Applicant
- Starion Instruments
- Decision
- Substantially Equivalent
- Date received
- 2000-08-17
- Decision date
- 2000-10-20
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- HQP
- Device class
- 2
- Regulation number
- 886.4115
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Saratoga, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.