Cleared Special

K092136 - PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
(FDA 510(k) Clearance)

K092136 · Isoray Medical, Inc. · Radiology

Aug 2009

Decision

23d

Days

Class 2

Risk

K092136 is an FDA 510(k) clearance for the PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5. This device is classified as a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK).

Submitted by Isoray Medical, Inc. (Richland, US). The FDA issued a Cleared decision on August 7, 2009, 23 days after receiving the submission on July 15, 2009.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number	K092136 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2009
Decision Date	August 07, 2009
Days to Decision	23 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF