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510(k) K230801

Pathfinder Endoscope Overtube with Balloon Device by Neptune Medical, Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2023
Date Received
March 23, 2023
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.

  • K240853 — Pathfinder® CR System (June 27, 2024)
  • K211301 — Pathfinder Endoscope Overtube (May 28, 2021)
  • K210915 — Pathfinder Endoscope Cap (May 25, 2021)
  • K191415 — Pathfinder Endoscope Overtube (August 30, 2019)

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  • 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)
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