510(k) K843135
K843135 is an FDA 510(k) premarket notification submitted by Brimfield Scientific Instruments for the device "BRIMFIELD CANNULATED MAGNETIC RETRIEVER". The FDA issued a decision of Substantially Equivalent on September 26, 1984. The device falls under product code FCC (Endoscopic Magnetic Retriever), a Class II device regulated under 21 CFR 876.1500. Brimfield Scientific Instruments has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1984
- Date Received
- August 9, 1984
- 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