Cleared Traditional

POLYESTER SPONGE PATTIE

K862494 · American Silk Sutures, Inc. · Neurology
Jul 1986
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K862494 is an FDA 510(k) clearance for the POLYESTER SPONGE PATTIE, a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by American Silk Sutures, Inc. (Swampscott, US). The FDA issued a Cleared decision on July 30, 1986, 29 days after receiving the submission on July 1, 1986. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4700.

Submission Details

510(k) Number K862494 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1986
Decision Date July 30, 1986
Days to Decision 29 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

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

Similar Devices — HBA Neurosurgical Paddie

All 23
Codman Surgical Patties & Strips
K193346 · Integra LifeSciences Corporation · Nov 2020
MEDLINE NEURO SPONGE
K140369 · Medline Industries, Inc. · Sep 2014
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598 · American Surgical Company, LLC · Jun 2013
DELICOT
K121822 · American Surgical Company, LLC · Sep 2012
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
K073576 · Harod Enterprises, Inc. · Feb 2008
AESCULAP NEURO PATTIES
K062406 · Aesculap, Inc. · Sep 2006