K012584 is an FDA 510(k) clearance for the MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT. This device is classified as a Anesthesia Conduction Kit (Class II - Special Controls, product code CAZ).
Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on September 6, 2001, 27 days after receiving the submission on August 10, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5140. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance..
| 510(k) Number | K012584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2001 |
| Decision Date | September 06, 2001 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAZ - Anesthesia Conduction Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5140 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance. |