# K854714: X-Ray Detectable Cotton Balls

- Pathway: 510(k) (Traditional)
- Applicant: American Silk Sutures, Inc.
- Decided: Dec 17, 1985 after 25 days
- Product code: GDY (Gauze/Sponge, Internal, X-Ray Detectable)
- Device class: 1
- Regulation: 21 CFR 878.4450
- Recalls of this device: 37 (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
- Sep 18, 2024 · Class II · Z-0287-2025: Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove t
- Mar 31, 2016 · Class II · Z-1735-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1731-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1732-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1748-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1736-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1727-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1738-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1747-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1759-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1754-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1729-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1746-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1737-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1757-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1758-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1750-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1728-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1743-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1734-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1745-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1742-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1755-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1740-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1756-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1744-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1730-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1749-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1762-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1752-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1733-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1741-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1724-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1723-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1760-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1753-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1739-2016: Product packaging defective compromising sterility

Source page: https://510kreport.com/device/K854714
Methodology: https://510kreport.com/methodology