510(k) K201166
K201166 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Temno Elite Biopsy System". The FDA issued a decision of Substantially Equivalent on Aug 28, 2020. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 28, 2020
- Date Received
- May 1, 2020
- 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)