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510(k) K150789

SPINAUT-E, SPINAUT-I by Imedicom Co., Ltd. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2016
Date Received
March 25, 2015
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.

  • K182287 — MEDINAUT Plus (April 6, 2019)
  • K173541 — EPINAUT (August 24, 2018)
  • K153296 — MEDINAUT Kyphoplasty System (July 29, 2016)
  • K150915 — SPINAUT-P (March 18, 2016)
  • K151268 — SPINAUT-V, SPINAUT-S, SPINAUT-I (March 16, 2016)

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  • K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Nex (August 30, 2023)
  • 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)
  • K173541 — EPINAUT (August 24, 2018)
  • 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)