# K994023: Haemacure Hemamyst Surgical Applicator System H-AS01

- Pathway: 510(k) (Traditional)
- Applicant: Haemacure Corp.
- Decided: Apr 25, 2000 after 151 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
Longest line of descent: 1 generation back to K964597 (1997). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964597: Biosurgical, Corp. Multi Chamber Suction Syringe, Biosurgical Corp. (1997) Summary page 1.

## Most influential descendants
- K050998: Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063 (2005), 1 descendant of its own
- K070814: Modification to Confluent Surgical Micromyst Applicator and Air Pump (2007), 0 descendants of its own
- K041504: Hemamyst Surgical Applicator System, Model H-AS01 (2004), 0 descendants of its own

## Indications for use
Haemacure HemaMyst Surgical Applicator System is indicated for the application of two non-homogeneous fluids or solutions to the treatment site.

Source page: https://510kreport.com/device/K994023
Methodology: https://510kreport.com/methodology