E-Pack Procedure Kits
by Ethicon Inc.
510(k) K951476
E-Pack Procedure Kits is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K951476 on 23 May 1995, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK951476 | Date23 May 1995 | StatusActive |
Official records
- FDA 510(k) database K951476
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MCY
- FDA applicant
- ETHICON, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5075
- Advisory committee
- General Hospital
- FDA decision
- SESK Substantially Equivalent — Kit
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Other devices filed under FDA product code MCY (Wound Dressing Kit).
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- ROUTINE DRESSING TRAY by Orion Life Systems, Inc.
- WOUND DRESSING KIT by Kit Pak, Inc.
- CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY by Grand Medical Products
- Circulon System Step 2 by Convatec, A Division of E.R. Squibb & Sons
- VARIOUS NON-STERILE CUSTOM TRAYS/KITS by Surgipro Central, Inc.