Product code IWR— Radiology

ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD

Classification name: Holder, Syringe, Lead
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Total cleared: 4
First cleared: 1981-07-02
Most recent: 1994-02-19

Market context for product code IWR

FDA has cleared 4 devices under product code IWR between 1981 and 1994, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19941 clearance
19872 clearances
19811 clearance

Top applicants under product code IWR

Viox Corp.2 clearances
Victoreen, Inc.1 clearance
Medi-Physics Inc. Dba Nycomed Amersham Imaging1 clearance

Recent clearances under product code IWR

K934549 — ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELDVictoreen, Inc.·1994-02-19
K872656 — LEAD GLASS SHIELDSViox Corp.·1987-07-16
K863936 — DUFFY BOLUS INJECTORViox Corp.·1987-01-06
K811688 — TUNGSTEN SYRINGE SHIELDMedi-Physics Inc. Dba Nycomed Amersham Imaging·1981-07-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.