IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
FDA 510(k) clearance K971832 · decided 1997-07-31
Clearance details
- K-number
- K971832
- Device name
- IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
- Applicant
- M-Pact Worldwide Management Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-19
- Decision date
- 1997-07-31
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- HOZ
- Device class
- 2
- Regulation number
- 886.4790
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Eudora, KS, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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
| Record | Firm | Date |
|---|---|---|
| Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from th recall (Z-0798-2025) | Carwild Corporation | 2025-01-02 |
| Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures recall (Z-0799-2025) | Carwild Corporation | 2025-01-02 |