All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV Reservoir

FDA 510(k) K980917 · Fortune Medical Instrument Corp.

Substantially Equivalent

510(k) numberK980917

Submission

Device name
All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV Reservoir
Applicant
Fortune Medical Instrument Corp.
Irvine, CA, US
Received
March 11, 1998
Decision date
May 27, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5010
Specialty
Gastroenterology, Urology

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More from Wilson-Cook Medical, Inc.

510(k)DeviceDecision
K022112Fortune All Silicone Stomach (Gastric) Tubes, Model 2020KNT · Traditional 04/03/2003SE
K021193Fortune Silicone Vacuum Suction, Model #1300HDB · Traditional 02/12/2003SE
K021142All Silicone Hematuria Catheter, Models 4861, 4862, 4863, 4864, 4865EZL · Traditional 10/01/2002SE
K014002All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional 03/04/2002SE
K980919All Silicone 2-WAY & 3-WAY Foly Balloon Catheter and Nelaton CatheterEZL · Traditional 03/31/1998SE

Questions and answers

When was All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV Reservoir cleared by the FDA?

All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV Reservoir (K980917) received a 510(k) decision of Substantially Equivalent on May 27, 1998, 77 days after the submission was received.

What is the product code of K980917?

The FDA product code is GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, a Class II (moderate risk) device regulated under 21 CFR 876.5010.