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510(k) K150083

Sidecar External Working Channel by C2 Therapeutics — Product Code FED

K150083 is an FDA 510(k) premarket notification submitted by C2 Therapeutics for the device "Sidecar External Working Channel". The FDA issued a decision of Substantially Equivalent on April 14, 2015. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. C2 Therapeutics has at least 9 other 510(k) clearances on record.

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

  • K163684 — C2 CryoBalloon Ablation System (January 23, 2018)
  • 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)

Other clearances for product code FED

  • K262262 — Pathfinder Endoscope Overtube (September 18, 2026)
  • K260410 — Single Use Ureteral Access Sheath (September 11, 2026)
  • K261915 — Navigator™ Flex Ureteral Access Sheath Set (August 4, 2026)
  • K260965 — CVAC Aspiration System (April 13, 2026)
  • K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100- (April 6, 2026)
  • K252572 — Prodeon Urethral Sheath System (October 7, 2025)
  • K250128 — Single Use Suction-Evacuation Ureteral Access Sheath (September 19, 2025)
  • 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)

FDA data resources