ALCON SITE(R)-COMPATIBLE CASSETTE
FDA 510(k) clearance K881682 · decided 1988-07-01
Clearance details
- K-number
- K881682
- Device name
- ALCON SITE(R)-COMPATIBLE CASSETTE
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1988-04-19
- Decision date
- 1988-07-01
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- KYG
- Device class
- 1
- Regulation number
- 886.4360
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| MED-LOGICS DISPOSABLE ALK TUBING (K010353) | Med-Logics, Inc. | 2001-04-27 |
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| BLADEWORKS DISPOSABLE ALK TUBING (K993591) | Blade Works, Inc. | 1999-12-28 |
| SOVEREIGN CATARACT EXTRACTION SYSTEM (K981116) | Allergan, Inc. | 1998-05-19 |
| EYE IRRIGATOR MODEL #2020 (K980647) | Eye-Deal Ocular Safety Products, Inc. | 1998-05-15 |
| MOISTAIR FLUID AIR TUBING SET (K974561) | American Medical Devices, Inc. | 1998-02-19 |
| ML DISPOSABLE ALK TUBING (K971173) | Med-Logics, Inc. | 1997-05-22 |
| HEDGES CORNEAL WETTING PAK (K970161) | Hedges Cwp, Inc. | 1997-03-25 |
| D.O.R.C. VFI/VFE SYSTEM (K954842) | Dutch Ophthalmic USA, Inc. | 1996-04-15 |
| DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (K945171) | Boston Surgical Products, Inc. | 1995-02-08 |
| PEREGRINE PIC MINIPULATOR (K940392) | Peregrine Surgical , Ltd. | 1994-08-23 |
| I/V POLE (K935226) | Optical Micro Systems, Inc. | 1994-02-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (P840064/S091) | Alcon Laboratories | 2025-10-03 |
| VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Ophthalmic Viscosurgical Device (P840064/S090) | Alcon Laboratories | 2025-07-25 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088) | Alcon Laboratories | 2025-02-26 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086) | Alcon Laboratories | 2024-08-12 |
| PMMA Single-Piece Anterior Chamber IOL (P880087/S033) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071) | Alcon Laboratories | 2024-06-20 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S085) | Alcon Laboratories | 2024-06-17 |