# K990689: Zynergy Lock-Sure Single Pass Drainage Catheter, Z10005/7/9

- Pathway: 510(k) (Traditional)
- Applicant: Zcv,Inc.
- Decided: Sep 3, 1999 after 184 days
- Product code: LJE (Catheter, Nephrostomy)
- 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 FDA summary names its predicate without a number.
- (no number) Elecath One-Step Fluid Drain Assembly: named in the summary without a submission number
- (no number) Dawson Mueller Drainage Catheter with Slip-Coat Hydrophillic Coating: named in the summary without a submission number

## Indications for use
Zynergy Loc-Sure Single Pass Drainage Assembly is a minimally invasive device for percutaneous drainage of cysts, abcesses and fluid collections such as: Renal cysts Renal, hepatic and other abcesses Pleural effusions Ascitic collections Thoracic collections Nephrostomies

Source page: https://510kreport.com/device/K990689
Methodology: https://510kreport.com/methodology