ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
FDA 510(k) K143164 · Kimberly-Clark Corporation
510(k) numberK143164
Submission
- Device name
- ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
- Applicant
- Kimberly-Clark Corporation
Irvine, CA, US - Received
- November 3, 2014
- Decision date
- December 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
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Questions and answers
When was ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set cleared by the FDA?
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set (K143164) received a 510(k) decision of Substantially Equivalent on December 2, 2014, 29 days after the submission was received.
What is the product code of K143164?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.