Cleared Special

Bi-Blade Vitrectomy Cutter

K153168 · Medical Instrument Development Laboratories · Ophthalmic

Apr 2016

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K153168 is an FDA 510(k) clearance for the Bi-Blade Vitrectomy Cutter, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Medical Instrument Development Laboratories (San Leandro, US). The FDA issued a Cleared decision on April 29, 2016, 179 days after receiving the submission on November 2, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K153168 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2015
Decision Date	April 29, 2016
Days to Decision	179 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF