US Endoscopy Distal Attachment Cap
FDA 510(k) K140315 · United States Endoscopy Group, Inc.
510(k) numberK140315
Submission
- Device name
- US Endoscopy Distal Attachment Cap
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- February 10, 2014
- Decision date
- April 4, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 US Endoscopy Distal Attachment Cap cleared by the FDA?
US Endoscopy Distal Attachment Cap (K140315) received a 510(k) decision of Substantially Equivalent on April 4, 2014, 53 days after the submission was received.
What is the product code of K140315?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.