# P990004: Surgifoam Absorbable Gelatin Sponge, Usp

- Pathway: PMA
- Applicant: Ferrosan Meidcal Devices A/S
- Decided: Sep 30, 1999 after 251 days
- Product code: LMF (Agent, Absorbable Hemostatic, Collagen Based)
- Device class: 3
- Regulation: 21 CFR 878.4490
- Recalls of this device: 5 (2 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.
1 of 1 device in its family (counting itself) has 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
- Apr 23, 2024 · Class II · Z-1881-2024: Some applicator tips from these lots had open seals.
- May 25, 2022 · Class II · Z-1584-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Aug 21, 2012 · Class I · Z-0293-2013: SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
- Aug 21, 2012 · Class I · Z-0292-2013: SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
- Apr 3, 2012 · Class II · Z-1897-2012: The lyophilized thrombin component of the Surgiflo Hemostatic Matrix kit with Thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process

Source page: https://510kreport.com/device/P990004
Methodology: https://510kreport.com/methodology