CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
FDA 510(k) clearance K991563 · decided 1999-10-13
Clearance details
- K-number
- K991563
- Device name
- CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
- Applicant
- Henke Sass Wolf of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-05
- Decision date
- 1999-10-13
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Duxbury, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.