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510(k) K261196

Promisemed VeriEcto Automatic Biopsy Needles by Promisemed Hangzhou Meditech Co., Ltd. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2026
Date Received
April 13, 2026
Clearance Type
Special
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

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