Cleared Traditional

Codman Surgical Patties & Strips

K193346 · Integra LifeSciences Corporation · Neurology
Nov 2020
Decision
353d
Days
Class 2
Risk

About This 510(k) Submission

K193346 is an FDA 510(k) clearance for the Codman Surgical Patties & Strips, a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by Integra LifeSciences Corporation (Mansfield, US). The FDA issued a Cleared decision on November 20, 2020, 353 days after receiving the submission on December 3, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4700.

Submission Details

510(k) Number K193346 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2019
Decision Date November 20, 2020
Days to Decision 353 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBA — Neurosurgical Paddie
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4700

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