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510(k) K122565

ARC ENDOCUFF by Boddingtons Plastics, Ltd. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2012
Date Received
August 22, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K151801 — Arc Endocuff Vision (August 13, 2015)

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