Glo-Tip Spray Catheter
FDA 510(k) K182319 · Wilson-Cook Medical, Inc.
510(k) numberK182319
Submission
- Device name
- Glo-Tip Spray Catheter
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- August 27, 2018
- Decision date
- February 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCX – Endoscopic Irrigation/Suction System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
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Questions and answers
When was Glo-Tip Spray Catheter cleared by the FDA?
Glo-Tip Spray Catheter (K182319) received a 510(k) decision of Substantially Equivalent on February 1, 2019, 158 days after the submission was received.
What is the product code of K182319?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.