# K112598: American Surgical Company/ Neurosurgical Sponges (Brand)

- Pathway: 510(k) (Special)
- Applicant: American Surgical Company, LLC
- Decided: Jun 20, 2013 after 652 days
- Product code: HBA (Neurosurgical Paddie)
- Device class: 2
- Regulation: 21 CFR 882.4700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962807 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962807: American Surgical Sponges/Neurosurgical Sponges, American Surgical Sponges (1997) Summary page 2.

## Indications for use
The device is indicated for use by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

Source page: https://510kreport.com/device/K112598
Methodology: https://510kreport.com/methodology