# K935199: Surgical Apparel

- Pathway: 510(k) (Traditional)
- Applicant: Associated Hospital Services, Inc.
- Decided: Sep 30, 1994 after 338 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K970286: Presbyterian Linen Services Surgical Packs (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K935199
Methodology: https://510kreport.com/methodology