# K904514: Strung Telfa Non-Adherent Sponge

- Pathway: 510(k) (Traditional)
- Applicant: American Silk Sutures, Inc.
- Decided: Mar 27, 1991 after 176 days
- Product code: HBA (Neurosurgical Paddie)
- Device class: 2
- Regulation: 21 CFR 882.4700
- Recalls of this device: 7 (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
- Mar 31, 2016 · Class II · Z-1800-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1805-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1804-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1802-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1806-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1803-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1801-2016: Product packaging defective compromising sterility

Source page: https://510kreport.com/device/K904514
Methodology: https://510kreport.com/methodology