Endoscopic Introducer
FDA 510(k) K123013 · Novadaq Technologies, Inc.
510(k) numberK123013
Submission
- Device name
- Endoscopic Introducer
- Applicant
- Novadaq Technologies, Inc.
Richmond British Columbia, CA - Received
- September 28, 2012
- Decision date
- March 22, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FED – Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
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Questions and answers
When was Endoscopic Introducer cleared by the FDA?
Endoscopic Introducer (K123013) received a 510(k) decision of Substantially Equivalent on March 22, 2013, 175 days after the submission was received.
What is the product code of K123013?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.