510(k) K904668
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1991
- Date Received
- October 15, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Magnetic Retriever
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
to endoscopically retrieve magnetic foreign objects