# K960787: Tur,Arthroscopic,Cystoscopy Irrigation Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 14, 1996 after 78 days
- Product code: LJH (System, Irrigation, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 4 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Current Baxter Irrigation Sets: named in the summary without a submission number

## Most influential descendants
- K254111: Irrigation/Urology Sets (2026), 0 descendants of its own

## Recalls of this device
- Jan 14, 2015 · Class II · Z-1010-2015: Potential for failure of the pouch packaging seal at high altitudes.
- May 15, 2013 · Class II · Z-1683-2013: A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the ster
- May 15, 2013 · Class II · Z-1684-2013: A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the ster
- May 15, 2013 · Class II · Z-1682-2013: A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the ster

## Indications for use
Baxter’s line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

Source page: https://510kreport.com/device/K960787
Methodology: https://510kreport.com/methodology