GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
FDA 510(k) clearance K994166 · decided 1999-12-27
Clearance details
- K-number
- K994166
- Device name
- GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
- Applicant
- Gyrus Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-09
- Decision date
- 1999-12-27
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cardiff, Wales, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.