510(k) K943989
K943989 is an FDA 510(k) premarket notification submitted by Gabris Surgical Corp. for the device "LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT". The FDA issued a decision of Substantially Equivalent on September 12, 1994. The device falls under product code HFO (Recorder, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Gabris Surgical Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1994
- Date Received
- August 16, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type