# IWJ: System, Applicator, Radionuclide, Manual

- Device class: 1; regulation: 21 CFR 892.5650; FDA's rule: 510(k) exempt
- FDA decisions: 36
- Recalls: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1990: 2
- 1991: 2
- 1992: 3
- 1993: 1
- 1994: 3
- 1995: 1
- 1996: 3
- 1997: 2
- 1998: 5
- 2001: 1

## Most-cited predicates
- K890341: Mick 200-TP and Mick TP Needle (1989), cited by 4
- K913293: Quick Seeder (1992), cited by 4
- K871216: Hilaris-Nori Endometrial Applicator (1987), cited by 3
- K910862: Various Template Applicators (1991), cited by 2
- K871217: Henschke Afterloading Applicator (1987), cited by 2
- K890485: Wang Front Loading Applicator (1989), cited by 1
- K903403: CT-Compatible Fletcher System Applicator (1990), cited by 1
- K973184: Prostate Seeding Needle (1997), cited by 1
- K933410: Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of Radioactive Seeds/Sources (1994), cited by 1
- K921886: Needle Technologies Seed Implant Needle (1992), cited by 1

Source page: https://510kreport.com/product-code/IWJ
Data by year (CSV): https://510kreport.com/product-code/IWJ.csv