510(k) K242029
K242029 is an FDA 510(k) premarket notification submitted by H.S Hospital Service S.P.A for the device "TRAP EASY". The FDA issued a decision of Substantially Equivalent on October 9, 2024. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. H.S Hospital Service S.P.A has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2024
- Date Received
- July 11, 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