Giltech Plus Connecting Tube Set

FDA 510(k) K983624 · Giltech Plus, Inc.

Substantially Equivalent

510(k) numberK983624

Submission

Device name
Giltech Plus Connecting Tube Set
Applicant
Giltech Plus, Inc.
Milford, PA, US
Received
October 15, 1998
Decision date
March 18, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KDH – Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KDH

510(k)DeviceApplicantDecision
K981286Superflow Irrigation and Aspiration Tubing SetsKDH · Traditional Armm, Inc.06/19/1998SE
K971259Combiport Fluid Lavage DeviceKDH · Traditional B.Braun Medical, Inc.10/27/1997SE
K962850Tum-E-VacKDH · Traditional Ethox Corp.02/21/1997SE
K951533Easi-Lav Pediatric / Adult Gastric Lavage KitKDH · Traditional Ballard Medical Products07/05/1995SE
K923497Flushing Irrigation SetKDH · Traditional Orion Life Systems, Inc.03/21/1994SESK
K920619Tri-Med Gastric Lavage SystemKDH · Traditional Tri-Med Specialties, Inc.09/04/1992SE
K920527Tri-Med Quick-Step Gastric Lavage KitKDH · Traditional Tri-Med Specialties, Inc.09/04/1992SE
K914908Quicvage PlusKDH · Traditional Autovage04/13/1992SESK
K914907QuicvageKDH · Traditional Autovage01/24/1992SE
K911919Minivage(R)KDH · Traditional Autovage07/26/1991SE

More from Autovage

510(k)DeviceDecision
K992094Giltech Plus Hydrogel Skin DressingNAE · Traditional 09/17/1999SE
K992005Giltech Plus Transparent DressingMGP · Traditional 09/03/1999SE

Questions and answers

When was Giltech Plus Connecting Tube Set cleared by the FDA?

Giltech Plus Connecting Tube Set (K983624) received a 510(k) decision of Substantially Equivalent on March 18, 1999, 154 days after the submission was received.

What is the product code of K983624?

The FDA product code is KDH – Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration, a Class II (moderate risk) device regulated under 21 CFR 876.5980.