Safety Screw Connector
FDA 510(k) K113719 · Abbott Laboratories
510(k) numberK113719
Submission
- Device name
- Safety Screw Connector
- Applicant
- Abbott Laboratories
Columbus, OH, US - Received
- December 19, 2011
- Decision date
- April 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Safety Screw Connector cleared by the FDA?
Safety Screw Connector (K113719) received a 510(k) decision of Substantially Equivalent on April 20, 2012, 123 days after the submission was received.
What is the product code of K113719?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.