Cleared Traditional

K935529 - CERVICAL SELF-RETAINING RETRACTOR
(FDA 510(k) Clearance)

K935529 · T. Korossurgical Instruments Corp. · Neurology device

Mar 1994

Decision

126d

Days

Class 2

Risk

K935529 is an FDA 510(k) clearance for the CERVICAL SELF-RETAINING RETRACTOR. This device is classified as a Retractor, Self-retaining, For Neurosurgery (Class II - Special Controls, product code GZT).

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on March 22, 1994, 126 days after receiving the submission on November 16, 1993.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.

Submission Details

510(k) Number	K935529 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 16, 1993
Decision Date	March 22, 1994
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement