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510(k) K240853

Pathfinder® CR System by Neptune Medical, Inc. — Product Code FED

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 27, 2024
Date Received
March 28, 2024
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 Neptune Medical, Inc.

  • K230801 — Pathfinder Endoscope Overtube with Balloon Device (July 28, 2023)
  • K211301 — Pathfinder Endoscope Overtube (May 28, 2021)
  • K210915 — Pathfinder Endoscope Cap (May 25, 2021)
  • K191415 — Pathfinder Endoscope Overtube (August 30, 2019)

Other clearances for product code FED

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  • 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)
  • 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)