510(k) K924271
K924271 is an FDA 510(k) premarket notification submitted by Core Medical, Inc. for the device "CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES". The FDA issued a decision of Substantially Equivalent on November 23, 1992. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Core Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1992
- Date Received
- August 24, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biopsy Needle
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type