Cleared Traditional

K890191 - HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
(FDA 510(k) Clearance)

K890191 · Amersham Corp. · Radiology

Feb 1989

Decision

19d

Days

Class 1

Risk

K890191 is an FDA 510(k) clearance for the HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN, a System, Applicator, Radionuclide, Manual (Class I — General Controls, product code IWJ), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on February 6, 1989, 19 days after receiving the submission on January 18, 1989. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5650.

Submission Details

510(k) Number	K890191 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 1989
Decision Date	February 06, 1989
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—