# K791871: Neurological Sponges (Patties)

- Pathway: 510(k) (Traditional)
- Applicant: Carwild Corp.
- Decided: Nov 5, 1979 after 45 days
- Product code: EFQ (Gauze/Sponge, Internal)
- Device class: U
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 7, 2026 · Class II · Z-2639-2026: Due to out-of-specification, or potential out-of-specification, levels of endotoxins
- Sep 28, 2022 · Class II · Z-0772-2023: Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

Source page: https://510kreport.com/device/K791871
Methodology: https://510kreport.com/methodology