Cleared Traditional

K180910 - ULTRAPRO Mesh and ULTRAPRO ADVANCED (FDA 510(k) Clearance)

K180910 · Ethicon, Inc. · General & Plastic Surgery device

Jul 2018

Decision

87d

Days

Class 2

Risk

K180910 is an FDA 510(k) clearance for the ULTRAPRO Mesh and ULTRAPRO ADVANCED. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on July 2, 2018, 87 days after receiving the submission on April 6, 2018.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K180910 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 2018
Decision Date	July 02, 2018
Days to Decision	87 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF