510(k) K243296
K243296 is an FDA 510(k) premarket notification submitted by Carbon (Shenzhen) Medical Device Co., Ltd. for the device "Disposable Biopsy Needle". The FDA issued a decision of Substantially Equivalent on July 11, 2025. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Carbon (Shenzhen) Medical Device Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2025
- Date Received
- October 18, 2024
- 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