510(k) K183146
K183146 is an FDA 510(k) premarket notification submitted by Ranfac Corporation for the device "Ranfac Cartilage Biopsy Needle". The FDA issued a decision of Substantially Equivalent on Apr 25, 2019. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Ranfac Corporation has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 25, 2019
- Date Received
- Nov 13, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type
- 510(k)