Cleared Special

Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs

K150428 · Integra Lifesciences Corp. · Neurology

Apr 2015

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K150428 is an FDA 510(k) clearance for the Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on April 16, 2015, 56 days after receiving the submission on February 19, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number	K150428 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2015
Decision Date	April 16, 2015
Days to Decision	56 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF