# P010047: Progel Pleural Air Leak Sealant

- Pathway: PMA
- Applicant: Neomend, Inc.
- Decided: Jan 14, 2010 after 3,066 days
- Product code: NBE (Sealant, Polymerizing)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Aug 13, 2012 · Class II · Z-2454-2012: Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.

Source page: https://510kreport.com/device/P010047
Methodology: https://510kreport.com/methodology