# K960955: Jackson-Pratt Gold Wound Drains with Duraflo II Coating

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 22, 1996 after 72 days
- Product code: GBX (Catheter, Irrigation)
- Device class: 1
- Regulation: 21 CFR 878.4200
- 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 FDA summary names its predicate without a number.
- (no number) Jackson-Pratt Wound Drains: named in the summary without a submission number
- (no number) Atrium PDR Thoracic Catheter: named in the summary without a submission number

## Indications for use
These drains are used in conjunction with non-powered single patient, portable suction apparatus. The drains provide a means to conduct fluids from a surgical wound via suction drainage.

Source page: https://510kreport.com/device/K960955
Methodology: https://510kreport.com/methodology