FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU— 510(k) K964441
Substantially EquivalentGynecare Innovation Center
FDA 510(k) clearance K964441 for FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU, Substantially Equivalent on 1997-03-28. Applicant: Gynecare Innovation Center. Device class: 2.
Clearance details
- Applicant
- Gynecare Innovation Center
- Product code
- Code KNF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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More clearances from Gynecare Innovation Center
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