Afx Introducer System
510(k) K120212
Afx Introducer System is a Class II device made by Endologix LLC, cleared under FDA 510(k) K120212 on 9 Feb 2012, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120212 | Date9 Feb 2012 | StatusActive |
Official records
- FDA 510(k) database K120212
Recalls
-
- Terminated Z-1436-2013
Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Timeline
- Cleared FDA 510(k) K120212
- Recall initiated FDA recalls Z-1436-2013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DYB
- FDA applicant
- Endologix, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent