Cleared Traditional

ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER

K080067 · Iscience Interventional · Ophthalmic

Jul 2008

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K080067 is an FDA 510(k) clearance for the ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER, a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Iscience Interventional (Menlo Park, US). The FDA issued a Cleared decision on July 18, 2008, 190 days after receiving the submission on January 10, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K080067 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2008
Decision Date	July 18, 2008
Days to Decision	190 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF