Cleared Traditional

K926585 - THOROCOSCOPY SELF-RETAINING RETRACTOR
(FDA 510(k) Clearance)

K926585 · T. Korossurgical Instruments Corp. · General & Plastic Surgery

Aug 1993

Decision

322d

Days

Class 1

Risk

K926585 is an FDA 510(k) clearance for the THOROCOSCOPY SELF-RETAINING RETRACTOR. This device is classified as a Retractor (Class I — General Controls, product code GAD).

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on August 6, 1993, 322 days after receiving the submission on September 18, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K926585 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 18, 1992
Decision Date	August 06, 1993
Days to Decision	322 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement