510(k) K931854
K931854 is an FDA 510(k) premarket notification submitted by Mayaguez Medical Center for the device "ENDOSCOPIC BLUNT DISSECTING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on August 10, 1993. The device falls under product code FGS (Carrier, Sponge, Endoscopic), a Class II device regulated under 21 CFR 876.1500. Mayaguez Medical Center has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1993
- Date Received
- April 13, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carrier, Sponge, Endoscopic
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type