510(k) K233294
K233294 is an FDA 510(k) premarket notification submitted by Itp Innovative Tomography Products GmbH for the device "Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM". The FDA issued a decision of Substantially Equivalent on June 18, 2024. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Itp Innovative Tomography Products GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2024
- Date Received
- September 29, 2023
- 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