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510(k) K143378

AQUARIUS Gastrostomy Replacement Tube by Degania Silicone , Ltd. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2014
Date Received
November 25, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Degania Silicone , Ltd.

  • K233591 — Stylus (May 31, 2024)
  • K152246 — Aquarius Stoma Measuring Device (June 21, 2016)
  • K141753 — AQUARIUS NASAL FEEDING TUBE (October 16, 2014)
  • K141631 — AQUARIUS EXTENSION FEEDING SET (July 28, 2014)
  • K132686 — AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE (May 12, 2014)
  • K131020 — TEMPERATURE SENSOR CATHETER (May 9, 2013)
  • K122030 — LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON (September 5, 2012)
  • K103371 — COUDE/ OR TIEMANN (March 11, 2011)
  • K070124 — GASTROSTOMY REPLACEMENT TUBE, MODEL 253 (May 23, 2007)
  • K063442 — ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR (March 26, 2007)

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