510(k) K971305
K971305 is an FDA 510(k) premarket notification submitted by Gynecare Innovation Center for the device "FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM". The FDA issued a decision of Substantially Equivalent on August 11, 1997. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Gynecare Innovation Center has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1997
- Date Received
- April 8, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type