Urosurge Acutrainer

FDA 510(k) K962770 · Princeton Regulatory Assoc.

Substantially Equivalent

510(k) numberK962770

Submission

Device name
Urosurge Acutrainer
Applicant
Princeton Regulatory Assoc.
Princeton, NJ, US
Received
July 16, 1996
Decision date
August 1, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KPN – Alarm, Conditioned Response Enuresis
Device class
Class II (moderate risk)
Regulation
21 CFR 876.2040
Specialty
Gastroenterology, Urology

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K130951SimKPN · Traditional Simavita Pty Limited08/22/2013SE
K971442Hughes Bladder and Bowel Training SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED…KPN · Traditional Humed, Inc.01/08/1998SE
K971855Potty Pal and Forever-DryKPN · Traditional Digital Applications, Inc.08/18/1997SE
K962416Drytime for Bladder Control SilentKPN · Traditional Bio-Systems Research07/22/1996SE
K955338Drytime for Potty TrainingKPN · Traditional Health Sense Intl., Inc.03/12/1996SE
K943559Remote A'LertKPN · Traditional Health Sense Intl., Inc.05/24/1995SE
K943558Pro'TectKPN · Traditional Health Sense Intl., Inc.05/24/1995SE
K942057Fisher-Price Dry Night MonitorKPN · Traditional Fisher Price07/28/1994SE
K935915Wet SenseKPN · Traditional Edson Corp.05/13/1994SE
K934369Dri SleeperKPN · Traditional Laborie Medical Technologies, Ltd.11/24/1993SE

More from Laborie Medical Technologies, Ltd.

510(k)DeviceDecision
K965136Urosurge Urotherm Fluid Warming SystemLHC · Traditional 10/16/1998SE
K972158Go Medical Patient Controlled Analgesia DevicesMEB · Traditional 02/20/1998SE
K973504Urosurge UrostentFAD · Traditional 01/30/1998SE

Questions and answers

When was Urosurge Acutrainer cleared by the FDA?

Urosurge Acutrainer (K962770) received a 510(k) decision of Substantially Equivalent on August 1, 1996, 16 days after the submission was received.

What is the product code of K962770?

The FDA product code is KPN – Alarm, Conditioned Response Enuresis, a Class II (moderate risk) device regulated under 21 CFR 876.2040.