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510(k) K162205

Arc EndoCuff and Arc EndoCuff Vision by Boddingtons Plastics, Ltd. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2016
Date Received
August 5, 2016
Clearance Type
Traditional
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 Boddingtons Plastics, Ltd.

  • K191330 — Arc Enterocuff (January 31, 2020)
  • K191067 — Arc Endocuff Glide AEG110 & AEG120 (May 30, 2019)
  • K151801 — Arc Endocuff Vision (August 13, 2015)
  • K122565 — ARC ENDOCUFF (September 4, 2012)

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