Tri-Med Quick-Step(Tm) Rectal Tube

FDA 510(k) K924549 · Tri-Med Specialties, Inc.

Substantially Equivalent

510(k) numberK924549

Submission

Device name
Tri-Med Quick-Step(Tm) Rectal Tube
Applicant
Tri-Med Specialties, Inc.
Overland Park, KS, US
Received
September 9, 1992
Decision date
February 10, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GBT – Catheter, Rectal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

Other 510(k)s with product code GBT

510(k)DeviceApplicantDecision
K941391Inflatable Retention Cuff SpeculumGBT · Traditional Innovatec Medical Corp.10/20/1994SE
K890466Sigmoid TonomitorGBT · Traditional Tonometrics, Inc.04/21/1989SE

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K970982T-Rx Retrieval ForcepsOCZ · Traditional 05/09/1997SE
K942918Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional 02/28/1995SE
K950574Needle/CannulaLRO · Traditional 02/24/1995SEKD
K934348Tri-Med Quick-Step Gastric Lavage Tube Sizes 18FR, 22FR, 32FRBSS · Traditional 12/23/1994SE
K945160Paracentesis Needles/CannulasLRO · Traditional 11/14/1994SE
K932015Tri-Med Inflatable Esophageal DilatorKNQ · Traditional 02/03/1994SE
K932652Tri-Med Paracentesis TrayLRO · Traditional 11/24/1993SEKD
K931201Tri-Med Endoscopic Fluid Introduction CatheterOCX · Traditional 09/28/1993SE

Questions and answers

When was Tri-Med Quick-Step(Tm) Rectal Tube cleared by the FDA?

Tri-Med Quick-Step(Tm) Rectal Tube (K924549) received a 510(k) decision of Substantially Equivalent on February 10, 1994, 519 days after the submission was received.

What is the product code of K924549?

The FDA product code is GBT – Catheter, Rectal, a Class II (moderate risk) device regulated under 21 CFR 876.5980.