XEN Glaucoma Treatment System
FDA 510(k) clearance K161457 · decided 2016-11-21
Clearance details
- K-number
- K161457
- Device name
- XEN Glaucoma Treatment System
- Applicant
- Allergan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-26
- Decision date
- 2016-11-21
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- KYF
- Device class
- 2
- Regulation number
- 886.3920
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Aliso Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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| Ahmed Glaucoma Valve Model FP8 (K171451) | New World Medical, Inc. | 2017-08-08 |
| Ahmed Glaucoma Valve (K162060) | New World Medical, Inc. | 2016-10-24 |
| Molteno3 Glaucoma Implant (K152996) | Innovative Ophthalmic Products, Inc. (Iop) | 2015-12-17 |
| MOLTENO3 (K062252) | Iop, Inc. | 2006-09-27 |
| AHMED GLAUCOMA VALVE, MODEL M4 (K060644) | New World Medical, Inc. | 2006-09-18 |
| EXPRESS MINI GLAUCOMA SHUNT (K030350) | Optonol, Ltd. | 2003-03-13 |
| EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS (K012852) | Optonol, Ltd. | 2002-03-26 |
| AHMED GLAUCOMA VALVE IMPLANT (K991072) | New World Medical, Inc. | 1999-07-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S011) | Allergan, Inc. | 2009-10-02 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S010) | Allergan, Inc. | 2008-01-11 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S009) | Allergan, Inc. | 2006-09-21 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S006) | Allergan, Inc. | 1997-07-11 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S005) | Allergan, Inc. | 1996-03-08 |
| CONTIGEN BARD COLLAGEN IMPLANT (P900030/S004) | Allergan, Inc. | 1996-02-01 |
| CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030/S003) | Allergan, Inc. | 1995-03-03 |
| CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030/S002) | Allergan, Inc. | 1994-11-23 |