# K964597: Biosurgical, Corp. Multi Chamber Suction Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Biosurgical Corp.
- Decided: Sep 8, 1997 after 294 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K994023: Haemacure Hemamyst Surgical Applicator System H-AS01 (2000), 3 descendants of its own
- K992351: Sealouette Fibrin Sealant Applicator (1999), 3 descendants of its own
- K050998: Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063 (2005), 1 descendant of its own
- K020666: Duploject Easy-Prep System 1ML, 2ML, 5ML (2002), 1 descendant of its own
- K014088: Duploreach (2002), 1 descendant of its own

## Indications for use
The BioSurgical Corp. Multi Chamber Suction Syringe is indicated for the mixing and application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.

Source page: https://510kreport.com/device/K964597
Methodology: https://510kreport.com/methodology