# K063190: Silverseal Wound Packing Strips with X-Static

- Pathway: 510(k) (Traditional)
- Applicant: Noble Fiber Technologies, Inc.
- Decided: Aug 21, 2007 after 305 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914579 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984210: Silverlon Wound Packing Strips, Argentum International, LLC (1999) Summary page 5.
- K012816: Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414, Dynarex Corp. (2002) Summary page 5.
- K052720: Medline Iodoform Packing Strips, Medline Industries, Inc. (2005) Summary page 5.
- K033587: Silverseal, Noble Fiber Technologies (2004) Summary page 5.
- K050649: Silverseal Contacting Wound Dressing with X-Static, Noble Fiber Technologies, Inc. (2005) Summary page 5.

## Indications for use
Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.

Source page: https://510kreport.com/device/K063190
Methodology: https://510kreport.com/methodology