Cleared Traditional

23ga Chandelier Illuminator, 25ga Chandelier Illuminator

K151604 · Peregrine Surgical , Ltd. · Ophthalmic
Sep 2015
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K151604 is an FDA 510(k) clearance for the 23ga Chandelier Illuminator, 25ga Chandelier Illuminator, a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Peregrine Surgical , Ltd. (New Britain, US). The FDA issued a Cleared decision on September 11, 2015, 88 days after receiving the submission on June 15, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K151604 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2015
Decision Date September 11, 2015
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MPA — Endoilluminator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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