Cleared Traditional

K131795 - NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS (FDA 510(k) Clearance)

K131795 · Orfit Industries NV · Radiology device
Sep 2013
Decision
100d
Days
Class 2
Risk

K131795 is an FDA 510(k) clearance for the NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).

Submitted by Orfit Industries NV (Wijnegem, BE). The FDA issued a Cleared decision on September 26, 2013, 100 days after receiving the submission on June 18, 2013.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K131795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2013
Decision Date September 26, 2013
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYE - Accelerator, Linear, Medical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.5050