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510(k) K151801

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2015
Date Received
July 2, 2015
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 Boddingtons Plastics, Ltd.

  • K191330 — Arc Enterocuff (January 31, 2020)
  • K191067 — Arc Endocuff Glide AEG110 & AEG120 (May 30, 2019)
  • K162205 — Arc EndoCuff and Arc EndoCuff Vision (December 9, 2016)
  • K122565 — ARC ENDOCUFF (September 4, 2012)

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