Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
FDA 510(k) K173105 · Cook Incorporated
510(k) numberK173105
Submission
- Device name
- Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- September 29, 2017
- Decision date
- March 22, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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Questions and answers
When was Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter cleared by the FDA?
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter (K173105) received a 510(k) decision of Substantially Equivalent on March 22, 2018, 174 days after the submission was received.
What is the product code of K173105?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.