ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
FDA 510(k) K161232 · Halyard Health
510(k) numberK161232
Submission
- Device name
- ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
- Applicant
- Halyard Health
Alpharetta, GA, US - Received
- May 2, 2016
- Decision date
- September 30, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit cleared by the FDA?
ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit (K161232) received a 510(k) decision of Substantially Equivalent on September 30, 2016, 151 days after the submission was received.
What is the product code of K161232?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.