Cleared Traditional

K983624 - GILTECH PLUS CONNECTING TUBE SET

K983624 is an FDA 510(k) clearance for GILTECH PLUS CONNECTING TUBE SET, manufactured by Giltech Plus, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDH cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K983624 · Giltech Plus, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
154d
Days
Class 2
Risk

K983624 is an FDA 510(k) clearance for the GILTECH PLUS CONNECTING TUBE SET. Classified as Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (product code KDH), Class II - Special Controls.

Submitted by Giltech Plus, Inc. (Milford, US). The FDA issued a Cleared decision on March 18, 1999 after a review of 154 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Giltech Plus, Inc. devices

FDA 510(k) Submission Details - K983624

510(k) Number K983624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date March 18, 1999
Days to Decision 154 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 130d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDH Device Classification - Class 2, Special Controls

Product Code KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration

Devices cleared under the same product code (KDH) and FDA review panel - the closest regulatory comparables to K983624.
COMBIPORT FLUID LAVAGE DEVICE
K971259 · B.Braun Medical, Inc. · Oct 1997
FLUSHING IRRIGATION SET
K923497 · Orion Life Systems, Inc. · Mar 1994
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · Baxter Healthcare Corp · Mar 1990
TUBING, AXIOM SILICONE PENROSE
K781749 · Axiom Medical, Inc. · Dec 1978
ARGYLE RAPID GASTRIC LAVAGE KIT
K770248 · Sherwood Medical Industries · Mar 1977
IRRIGATION CATHETER
K760556 · Sherwood Medical Industries · Feb 1977