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510(k) K123013

ENDOSCOPIC INTRODUCER by Novadaq Technologies, Inc. — Product Code FED

K123013 is an FDA 510(k) premarket notification submitted by Novadaq Technologies, Inc. for the device "ENDOSCOPIC INTRODUCER". The FDA issued a decision of Substantially Equivalent on March 22, 2013. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Novadaq Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2013
Date Received
September 28, 2012
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 Novadaq Technologies, Inc.

  • K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System (January 11, 2017)
  • K161792 — PINPOINT Endoscopic Fluorescence Imaging System (September 20, 2016)
  • K150956 — PINPOINT Endoscopic Fluorescence Imaging System (May 23, 2016)
  • K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM (February 4, 2011)
  • K091515 — SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM (July 9, 2009)
  • K081792 — SPY ANALYSIS TOOLKIT, MODEL SA9000 (September 17, 2008)
  • K073088 — SPY FLUORESCENT IMAGING SYSTEM (January 10, 2008)
  • K073130 — SPY FLUORESCENT IMAGING SYSTEM (January 10, 2008)
  • K071619 — SPY FLUORESCENT IMAGING SYSTEM (November 9, 2007)
  • K072222 — SPY FLUORESCENT IMAGING SYSTEM (September 7, 2007)

Other clearances for product code FED

  • 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)
  • 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)

FDA data resources