IWR — Holder, Syringe, Lead Class I
FDA product code IWR covers "Holder, Syringe, Lead", a Class I medical device regulated under 21 CFR 892.6500. Submissions are reviewed by the Radiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- IWR
- Device Class
- Class I
- Regulation Number
- 892.6500
- Submission Type
- 510(k) Exempt
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K934549 | Victoreen | ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD | Feb 19, 1994 |
| K872656 | Viox | LEAD GLASS SHIELDS | Jul 16, 1987 |
| K863936 | Viox | DUFFY BOLUS INJECTOR | Jan 6, 1987 |
| K811688 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | TUNGSTEN SYRINGE SHIELD | Jul 2, 1981 |