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510(k) K173541

EPINAUT by Imedicom Co., Ltd. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2018
Date Received
November 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type

Other clearances by Imedicom Co., Ltd.

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  • K153296 — MEDINAUT Kyphoplasty System (July 29, 2016)
  • K150915 — SPINAUT-P (March 18, 2016)
  • K151268 — SPINAUT-V, SPINAUT-S, SPINAUT-I (March 16, 2016)
  • K150789 — SPINAUT-E, SPINAUT-I (March 1, 2016)

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  • K193664 — SubQKath Catheter and Needle Set (September 9, 2020)
  • K200624 — Percutaneous Introducer (April 27, 2020)
  • K191470 — C-CAT Anaesthesia Catheter kit (October 25, 2019)
  • K181782 — Medline Reinforced Epidural Catheter (March 4, 2019)
  • K172777 — Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (May 3, 2018)
  • K171584 — B. Braun Tear-Away Introducer Needle (December 22, 2017)
  • K171193 — Certa Catheter (December 18, 2017)