Cleared Traditional

K926477 - BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO (FDA 510(k) Clearance)

K926477 · Core Dynamics, Inc. · General & Plastic Surgery device

Nov 1993

Decision

318d

Days

Class 1

Risk

K926477 is an FDA 510(k) clearance for the BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO. This device is classified as a Catheter, Peritoneal (Class I - General Controls, product code GBW).

Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 12, 1993, 318 days after receiving the submission on December 29, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K926477 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 29, 1992
Decision Date	November 12, 1993
Days to Decision	318 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement