# P830079: Instat (TM) Collagen Absorbable Hemostat

- Pathway: PMA
- Applicant: ETHICON, Inc.
- Decided: Oct 10, 1985 after 657 days
- Product code: LMF (Agent, Absorbable Hemostatic, Collagen Based)
- Device class: 3
- Regulation: 21 CFR 878.4490
- Recalls of this device: 2 (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
- Mar 28, 2013 · Class II · Z-1289-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- Mar 28, 2013 · Class II · Z-1288-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Source page: https://510kreport.com/device/P830079
Methodology: https://510kreport.com/methodology