510(k) K974028
K974028 is an FDA 510(k) premarket notification submitted by Conceptus, Inc. for the device "STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING". The FDA issued a decision of Substantially Equivalent on January 21, 1998. The device falls under product code MKO (Falloposcope), a Class II device regulated under 21 CFR 884.1690. Conceptus, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1998
- Date Received
- October 23, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Falloposcope
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type