# K962807: American Surgical Sponges/Neurosurgical Sponges

- Pathway: 510(k) (Traditional)
- Applicant: American Surgical Sponges
- Decided: May 2, 1997 after 288 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K904517: Mammospot 3 and Mammospot 8, American Mammographics, Inc. (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K112598: American Surgical Company/ Neurosurgical Sponges (Brand) (2013), 0 descendants of its own

## Indications for use
This device is intended to be used 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/K962807
Methodology: https://510kreport.com/methodology