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510(k) K180668

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N by Olympus Medical Systems Corp. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2018
Date Received
March 14, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

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Other clearances for product code FCG

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  • K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (May 30, 2023)
  • K212423 — EndoDrill® Model X (March 29, 2023)
  • K212819 — Disposable Biopsy Refill Needle (July 6, 2022)
  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
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