JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
FDA 510(k) clearance K960955 · decided 1996-05-22
Clearance details
- K-number
- K960955
- Device name
- JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1996-03-11
- Decision date
- 1996-05-22
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- GBX
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mcgaw Park, IL, US
- Third-party review
- No
- Expedited review
- No
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| GRAFTSAVER (K043515) | Vescare, Inc. | 2005-03-31 |
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| LYSONIX IRRIGATION SYSTEM (K974233) | Lysonix, Inc. | 1998-02-03 |
| JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (K973703) | Allegiance Healthcare Corp. | 1997-12-04 |
| ULTRACELL SUCTION SPONGE (K972635) | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| FLAT CLOSED WOUND DRAIN WITH TROCAR (K965146) | Axiom Medical, Inc. | 1997-03-10 |
| SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (K961295) | Sil-Med Corp. | 1996-06-26 |
| CLOSED FLUID COLLECTION SYSTEM (K961147) | B.Braun Medical, Inc. | 1996-05-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |