Duploject Easy Prep 1501251
Duploject Easy Prep 1501251 is an open-surgery adhesive/sealant applicator (FDA Class II; FDA product code FMF, Syringe, piston) made by Baxter International Inc., cleared under FDA 510(k) K020666 on 24 Jun 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00085412095844), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00085412095844 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020666 | Date24 Jun 2002 | StatusActive |
Official records
- AccessGUDID record 00085412095844
- FDA 510(k) database K020666
Across registries
- FDA 510(k) K020666 decided 24 Jun 2002 Active
- FDA GUDID UDI-DI 00085412095844 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-0263-2008
Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid.
Timeline
- Cleared FDA 510(k) K020666
- Recall initiated FDA recalls Z-0263-2008
- Listed FDA GUDID 00085412095844
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Duploject Easy Prep
- Generic name
- Open-surgery adhesive/sealant applicator, dual-channel
- Model / Ref / Catalog
- 1501251
- Primary DI / UDI-DI
- 00085412095844
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- Open-surgery adhesive/sealant applicator, dual-channel
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 4 Milliliter
Similar devices in this category
Other devices filed under Open-surgery adhesive/sealant applicator, dual-channel.