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510(k) K171208

Trans-anal Introducer by Visionsense, Ltd. — Product Code FED

K171208 is an FDA 510(k) premarket notification submitted by Visionsense, Ltd. for the device "Trans-anal Introducer". The FDA issued a decision of Substantially Equivalent on February 5, 2018. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Visionsense, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2018
Date Received
April 25, 2017
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 Visionsense, Ltd.

  • K223020 — VS3-Iridium System (VS3-IR) (October 28, 2022)
  • K210265 — VS3 Iridium Sytem (November 22, 2021)
  • K153548 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (February 22, 2016)
  • K152204 — VS3-IR system (October 28, 2015)
  • K150018 — VS3-IR-MMS System (June 17, 2015)
  • K141002 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (June 26, 2014)
  • K131434 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (July 16, 2013)
  • K123467 — VS3 (April 17, 2013)
  • K082355 — VISIONSENSE STEREOSCOPIC VISION SYSTEM (December 15, 2008)
  • K082667 — VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) (October 30, 2008)

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