510(k) K242029

TRAP EASY by H.S Hospital Service S.P.A — Product Code KNW

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