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510(k) K150083

Sidecar External Working Channel by C2 Therapeutics — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2015
Date Received
January 15, 2015
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 C2 Therapeutics

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  • K161202 — C2 Cryoballoon Ablation System (January 5, 2017)
  • K160994 — C2 CryoBalloon Focal Pear Catheter (May 19, 2016)
  • K152329 — Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablatio (April 13, 2016)
  • K153541 — Coldplay CryoBalloon® Ablation System (January 7, 2016)
  • K152140 — Boa Endoscopic Valve (October 13, 2015)
  • K151054 — Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablatio (July 7, 2015)
  • K131523 — CRYOBALLOON FOCAL ABLATION SYSTEM (August 22, 2013)
  • K101825 — CRYOBALLOON ABLATION SYSTEM (September 29, 2010)

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  • K250132 — Ureteral Access Sheath (September 5, 2025)
  • K250695 — Single-use Ureteral Access Sheath (July 8, 2025)
  • K251599 — Single-use Ureteral Access Sheath (July 3, 2025)
  • K250585 — LumenaTM Ureteral Access Sheath (June 27, 2025)
  • K250452 — CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0 (June 2, 2025)
  • K243710 — Disposable ureteral access sheath (April 11, 2025)
  • K250517 — Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator (March 21, 2025)
  • K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I (January 31, 2025)