FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
K Number: K964441
·
Decision Mar 28, 1997
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
8
Review Days
142
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Basic Information
- Device Name
- FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
- K Number
- K964441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gynecare Innovation Center
- Date Received
- November 6, 1996
- Decision Date
- March 28, 1997
- Product Code
- KNF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Gynecare Innovation Center
| K Number | Device Name | ||
|---|---|---|---|
| K980393 | SOPRANO CRYO-THERAPY SYSTEM | May 1, 1998 | Substantially Equivalent |
| K971305 | FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM | Aug 11, 1997 | Substantially Equivalent |
| K964892 | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) | Feb 4, 1997 | Substantially Equivalent |
| K963872 | FEMRX MORCELLATOR SYSTEM | Jan 17, 1997 | Substantially Equivalent |
| K962506 | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] | Sep 16, 1996 | Substantially Equivalent |
| K954775 | FLO-STAT FLUID MONITORING SYSTEM | May 10, 1996 | Substantially Equivalent |
| K954648 | FEMRX OPERASTAR SYSTEM | Mar 14, 1996 | Substantially Equivalent |