# K101547: Henke- Sass, Wolf Piston Syringe (Norm-Jet)

- Pathway: 510(k) (Traditional)
- Applicant: Henke-Sass, Wolf GmbH
- Decided: Nov 22, 2010 after 172 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: 4 generations back to K944355 (1994). 5 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K821537: Henke Disposable Syringe, C. B. Dumont Company, Inc. (1982) Summary page 2.
- K063280: Injekt Syringe, B.Braun Medical, Inc. (2006) Summary page 2.

## Most influential descendants
- K202432: MiniLoad Syringe (2021), 2 descendants of its own
- K231558: SMB Luer lock disposable syringe (2024), 0 descendants of its own
- K212544: MiniLoad Syringe (2021), 0 descendants of its own

## Indications for use
The HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with BOTOX® is exclusively produced for use with BOTOX® Cosmetic (onabotulinumtoxinA).

Source page: https://510kreport.com/device/K101547
Methodology: https://510kreport.com/methodology