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510(k) K131052

TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) by Actuated Medical, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2013
Date Received
April 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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  • K200646 — TubeClear System (December 4, 2020)
  • K172556 — TubeClear System (June 29, 2018)
  • K163092 — TubeClear Control Box and Clearing Stem (November 30, 2016)
  • K123659 — TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TU (December 20, 2012)
  • K121571 — TUBECLEAR (June 13, 2012)

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