Cleared Traditional

Wiggins Medical Surgical Instruments

K200383 · Wiggins Medical · Neurology

Jul 2020

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K200383 is an FDA 510(k) clearance for the Wiggins Medical Surgical Instruments, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Wiggins Medical (Cincinnati, US). The FDA issued a Cleared decision on July 21, 2020, 154 days after receiving the submission on February 18, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number	K200383 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 18, 2020
Decision Date	July 21, 2020
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF