FDA 510(k)

GR Resin System MSI

K-Number: K231775 · 2024-08-08

Decision Date2024-08-08

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

GR Resin System MSI is the device name listed in this FDA 510(k) record. The listed applicant is Pro3Dure Medical. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K231775. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GR Resin System MSI?

GR Resin System MSI is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Pro3Dure Medical. The 510(k) number is K231775.

When did GR Resin System MSI receive FDA 510(k) clearance?

GR Resin System MSI received FDA 510(k) clearance on 2024-08-08, under 510(k) number K231775.

Who is the listed applicant for GR Resin System MSI?

The FDA 510(k) record lists Pro3Dure Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GR Resin System MSI?

The FDA product code for GR Resin System MSI is MQC.

Other records listing Pro3Dure Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212017Thermeo System K211415GR Splint Resin System K210298GR-14 Resin System K201827GR-17 Resin System

Related Devices (Code: MQC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.