BIOLEX IMPREGNATED WOUND DRESSING
FDA 510(k) clearance K935096 · decided 1994-02-17
Clearance details
- K-number
- K935096
- Device name
- BIOLEX IMPREGNATED WOUND DRESSING
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-22
- Decision date
- 1994-02-17
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- MGQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Murray Hill, NJ, 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 |
|---|---|---|
| HylaGuard Moisturizing Cream (K171879) | Founders Science Group, LLC | 2017-10-16 |
| HYLATOPIC EMOLLIENT FOAM (K083024) | Collegium Pharmaceutical Incorporated | 2009-03-27 |
| IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (K041342) | Stiefel Laboratories, Inc. | 2005-07-19 |
| SILVERSITE OR CALGITROL (K041268) | Adri | 2004-09-20 |
| SILVERSEAL (K040019) | Noble Fiber Technologies | 2004-07-23 |
| TENDERWET ACTIVE (K040517) | Medline Industries, Inc. | 2004-03-25 |
| MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (K022587) | Medtrade Products , Ltd. | 2003-08-22 |
| SINCLAIR WOUND AND SKIN EMULSION (K024367) | Sinclair Pharmaceuticals, Ltd. | 2003-07-28 |
| XYLOS XCELL ANTIMICROBIAL DRESSING (K024054) | Xylos Corporation | 2003-03-07 |
| CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (K022584) | Cardiotech Intl. | 2002-12-30 |
| COLLATEK HYDROGEL (K022995) | Biocore Medical Technologies, Inc. | 2002-12-02 |
| CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) (K013525) | Coloplast Corp. | 2002-10-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |