Product code IWG— Radiology
BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
- Classification name
- Seed, Isotope, Gold, Titanium, Platinum
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code IWG
FDA has cleared devices under product code IWG between 1983 and 2008, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 1998
- 1983
Top applicants under product code IWG
Recent clearances under product code IWG
Data sourced from openFDA. This site is unofficial and independent of the FDA.