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510(k) K163092

TubeClear Control Box and Clearing Stem by Actuated Medical, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2016
Date Received
November 4, 2016
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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  • K231254 — GripTract-GI Endoscopic Tissue Manipulator (November 3, 2023)
  • K220890 — IO Needle Safety Sheath (October 31, 2022)
  • K200646 — TubeClear System (December 4, 2020)
  • K172556 — TubeClear System (June 29, 2018)
  • K131052 — TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) (August 16, 2013)
  • 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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  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
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