E-PACK PROCEDURE KITS
FDA 510(k) clearance K951476 · decided 1995-05-23
Clearance details
- K-number
- K951476
- Device name
- E-PACK PROCEDURE KITS
- Applicant
- ETHICON, Inc.
- Decision
- Unknown
- Date received
- 1995-03-30
- Decision date
- 1995-05-23
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- MCY
- Device class
- 2
- Regulation number
- 880.5075
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Somerville, 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 |
|---|---|---|
| DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (K970721) | Johnson & Johnson Medical, Inc. | 1997-03-21 |
| CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (K963719) | Grand Medical Products | 1996-11-27 |
| WOUND CARE COMPRESSION SYSTEM (WCCS) (K960585) | Suncoast Medical Products, Inc. | 1996-04-26 |
| DRESSING CHANGE TRAY (K952334) | Busse Hospital Disposables, Inc. | 1995-07-14 |
| CIRCULON SYSTEM STEP 1 (K951022) | Convatec, A Division of E.R. Squibb & Sons | 1995-06-12 |
| CIRCULON SYSTEM STEP 2 (K951021) | Convatec, A Division of E.R. Squibb & Sons | 1995-06-12 |
| DRESSING CHANGE TRAY-MODIFIED (K931932) | Medsurg Industries, Inc. | 1993-08-27 |
| VARIOUS NON-STERILE CUSTOM TRAYS/KITS (K924690) | Surgipro Central, Inc. | 1993-07-16 |
| WOUND DRESSING KIT (K923905) | Kit Pak, Inc. | 1993-07-02 |
| TPN TRAY (STERILE) (K925021) | Customed, Inc. | 1993-06-07 |
| PER-Q-CATH DRESSING CHANGE TRAY (K926063) | Gesco Intl., Inc. | 1993-06-07 |
| CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER (K921347) | Medi-Flex Hospital Products, Inc. | 1993-01-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |