RI Witness Embryology Heated Plate— 510(k) K160504

Clearance details

Applicant

Research Instruments Limited

Product code

Code MQG

Device class

Class 2

Regulation

21 CFR 884.6120

Advisory panel

Obstetrics/Gynecology

Date received

2016-02-24

Decision date

2016-07-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Falmouth, GB

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• Z-0029-2020 — Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.Class III·Terminated·CooperSurgical, Inc.·20190905

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160504.