# K973511: Kendall Curity Petrolatum Gauze

- Pathway: 510(k) (Traditional)
- Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
- Decided: Dec 16, 1997 after 90 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sherwood Medical Vaseline Petrolatum Gauze Dressing: named in the summary without a submission number

## Most influential descendants
- K984069: Entaxis Nasal Packing (1999), 37 descendants of its own
- K993362: Hylasine (2000), 35 descendants of its own
- K033666: Hemaderm (2003), 29 descendants of its own
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), 28 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own

## Indications for use
It is intended for use as a primary layer in dressing wounds such as minor burns, skin grafts, skin donor sites, as an initial layer in surgical dressings, as protective layer for injured body sites, as a seal around tubes and drains leading from the body.

Source page: https://510kreport.com/device/K973511
Methodology: https://510kreport.com/methodology