510(k) K162588
K162588 is an FDA 510(k) premarket notification submitted by Moller Medical GmbH for the device "Möller Medical Biopsy Needles and Systems". The FDA issued a decision of Substantially Equivalent on Jun 19, 2017. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Moller Medical GmbH has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 19, 2017
- Date Received
- Sep 16, 2016
- 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)