# K964620: Panogauze Non-Woven Hydrogel Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Sage Pharmaceuticals, Inc.
- Decided: Jan 9, 1997 after 52 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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.
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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K915001: Carrington Wound Dressing 4X4(TM), Carrington Laboratories, Inc. (1992). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
PanoGauze™ Non-Woven Hydrogel Dressing, like the CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, is intended to provide a moist packing/healing environment which helps to prevent wound desiccation.

Source page: https://510kreport.com/device/K964620
Methodology: https://510kreport.com/methodology