ALCON SURGICAL SPONGE
FDA 510(k) clearance K896004 · decided 1989-11-02
Clearance details
- K-number
- K896004
- Device name
- ALCON SURGICAL SPONGE
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-10-13
- Decision date
- 1989-11-02
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- HOZ
- Device class
- 2
- Regulation number
- 886.4790
- 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 |
|---|---|---|
| SUNTOUCH EYE SPEAR (K132796) | Huizhou Foryou Medical Devices Co., Ltd. | 2013-10-30 |
| NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (K130117) | Network Medical Products, Ltd. | 2013-10-29 |
| ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (K091240) | Alphamed, Inc. | 2009-10-23 |
| CENEFOM PVA SURGICAL SPEAR (K082460) | Longtek Scientific Co., Ltd. | 2008-12-15 |
| ULTRACELL ABSORBENT STICK (K012196) | Ultracell Medical Technologies, Inc. | 2001-08-24 |
| MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (K011191) | Medtronic Xomed, Inc. | 2001-06-26 |
| PRESCOTT'S SURGICAL SPEAR (K003842) | Prescott'S, Inc. | 2001-04-13 |
| ML EYE SPEAR, MODEL ML 27 ES (K002279) | Med-Logics, Inc. | 2000-08-18 |
| M-PACT CORNEAL LIGHT SHIELD (K993883) | M-Pact Corp. | 1999-12-21 |
| DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE (K990671) | Hurricane Medical | 1999-05-10 |
| SOF-SUCTION FLUID EVACUATION SYSTEM (K990749) | X-Tech Medical, LLC | 1999-04-02 |
| THE FREMSTAD RING (K982599) | Ophthalmic Solutions, LLC | 1999-02-16 |
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 |