# K941269: Gore Smoother II and Gore BPTB

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 19, 1994 after 64 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K962765: Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom with Radiopaque Markers) (1997), 2 descendants of its own
- K993248: Amplatzer Sizing Balloon (2000), 1 descendant of its own
- K053440: Amplatzer Sizing Balloon II (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K941269
Methodology: https://510kreport.com/methodology