# K882708: Gauze Sponge, X-Ray Detectable

- Pathway: 510(k) (Traditional)
- Applicant: Bioseal
- Decided: Aug 3, 1988 after 37 days
- Product code: GDY (Gauze/Sponge, Internal, X-Ray Detectable)
- Device class: 1
- Regulation: 21 CFR 878.4450
- Recalls of this device: 4 (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
- Jul 1, 2025 · Class II · Z-2284-2025: Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Jul 1, 2025 · Class II · Z-2283-2025: Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Jul 1, 2025 · Class II · Z-2282-2025: Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Jul 1, 2025 · Class II · Z-2281-2025: Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

Source page: https://510kreport.com/device/K882708
Methodology: https://510kreport.com/methodology