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510(k) K120126

BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE by Barosense, Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2012
Date Received
January 17, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Other clearances by Barosense, Inc.

  • K120147 — ACE STAPLER AND CARTRIDGE (February 17, 2012)
  • K110829 — ACE STAPLER AND CARTRIDGE (June 3, 2011)
  • K082044 — ACE STAPLER, MODEL F0031 (May 11, 2010)
  • K082589 — BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 (May 22, 2009)

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