# K961295: Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Sil-Med Corp.
- Decided: Jun 26, 1996 after 83 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
Longest line of descent: 1 generation back to K926408 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942709: Mediastinal Silicone Drains, Sil-Med Corp. (1996) Summary page 1.
- K926408: Sil-Slip Flat Suction Drain, Sil-Med Corp. (1994) Summary page 1.

## Most influential descendants
- K063245: Elutia  Coated Closed Surgical Wound Drain (2007), 0 descendants of its own

## Indications for use
For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction reservoir as a closed wound drain system

Source page: https://510kreport.com/device/K961295
Methodology: https://510kreport.com/methodology