Non-A-Therm

FDA 510(k) K792037 · Labarge, Inc.

Substantially Equivalent

510(k) numberK792037

Submission

Device name
Non-A-Therm
Applicant
Labarge, Inc.
Mchenry, IL, US
Received
October 11, 1979
Decision date
November 13, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KOD – Catheter, Urological
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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K180354UroGen Ureteral CatheterKOD · Traditional Urogen Pharma, Ltd.10/30/2018SE
K181144Angled Tip Ureteral CatheterKOD · Traditional Cook Incorporated06/28/2018SE
K180530Imager II Urology Torque CatheterKOD · Special Boston Scientific Corporation04/10/2018SE
K171810Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional Cook Incorporated03/07/2018SE
K171600Renal Access Cobra Catheter, Kumpe Access CatheterKOD · Traditional Cook Incorporated02/16/2018SE

More from Cook Incorporated

510(k)DeviceDecision
K771520Esophageal StethoscopeDQD · Traditional 09/23/1977SE
K771411Esophageal Steth. Temp. SensorBZW · Traditional 09/23/1977SE
K760720Mon-A-Therm Temparature Monitor SysFLL · Traditional 11/30/1976SE

Questions and answers

When was Non-A-Therm cleared by the FDA?

Non-A-Therm (K792037) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 33 days after the submission was received.

What is the product code of K792037?

The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.