Spirol Epidural Catheter
FDA 510(k) K000886 · Abbott Laboratories
510(k) numberK000886
Submission
- Device name
- Spirol Epidural Catheter
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- March 20, 2000
- Decision date
- October 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Spirol Epidural Catheter cleared by the FDA?
Spirol Epidural Catheter (K000886) received a 510(k) decision of Substantially Equivalent on October 5, 2000, 199 days after the submission was received.
What is the product code of K000886?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.