Cleared Traditional

K073552 - LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
(FDA 510(k) Clearance)

K073552 · Laborie Medical Technologies, Corp. · Gastroenterology & Urology device

Mar 2008

Decision

78d

Days

Class 2

Risk

K073552 is an FDA 510(k) clearance for the LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY. This device is classified as a Device, Cystometric, Hydraulic (Class II - Special Controls, product code FEN).

Submitted by Laborie Medical Technologies, Corp. (Williston, US). The FDA issued a Cleared decision on March 5, 2008, 78 days after receiving the submission on December 18, 2007.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.

Submission Details

510(k) Number	K073552 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 18, 2007
Decision Date	March 05, 2008
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF