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510(k) K182403

Peel-Away Introducer by Cook Incorporated — Product Code FED

K182403 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Peel-Away Introducer". The FDA issued a decision of Substantially Equivalent on May 29, 2019. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Cook Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2019
Date Received
September 4, 2018
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 Cook Incorporated

  • K233177 — Nest VT Vitrification Device (March 8, 2024)
  • K222254 — Gunther Tulip Vena Cava Filter Retrieval Set (May 16, 2023)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)
  • K203670 — Extra Large Check-Flo Introducer (February 16, 2021)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K191163 — Lumax Guiding Catheter (December 12, 2019)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K190084 — McLean-Ring Enteral Feeding Tube Set (October 11, 2019)

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