SOVEREIGN CATARACT EXTRACTION SYSTEM
FDA 510(k) clearance K981116 · decided 1998-05-19
Clearance details
- K-number
- K981116
- Device name
- SOVEREIGN CATARACT EXTRACTION SYSTEM
- Applicant
- Allergan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-27
- Decision date
- 1998-05-19
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- KYG
- Device class
- 1
- Regulation number
- 886.4360
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use. recall (Z-0130-2024) | B. Braun Medical, Inc. | 2023-11-03 |
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 |