Stryker Infrared Fluorescence (IRF) Imaging System
FDA 510(k) K142310 · Stryker Endoscopy
510(k) numberK142310
Submission
- Device name
- Stryker Infrared Fluorescence (IRF) Imaging System
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- August 19, 2014
- Decision date
- December 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
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Questions and answers
When was Stryker Infrared Fluorescence (IRF) Imaging System cleared by the FDA?
Stryker Infrared Fluorescence (IRF) Imaging System (K142310) received a 510(k) decision of Substantially Equivalent on December 2, 2014, 105 days after the submission was received.
What is the product code of K142310?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.