Cleared Traditional

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip

K161275 · Research Instruments Limited · Obstetrics & Gynecology

Jan 2017

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K161275 is an FDA 510(k) clearance for the EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip, a Microtools, Assisted Reproduction (pipettes) (Class II — Special Controls, product code MQH), submitted by Research Instruments Limited (Falmouth, GB). The FDA issued a Cleared decision on January 23, 2017, 262 days after receiving the submission on May 6, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6130.

Submission Details

510(k) Number	K161275 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2016
Decision Date	January 23, 2017
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF