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FDA 510(k)

UROSURGE ACUTRAINER

K-Number: K962770 · 1996-08-01

ApplicantPrinceton Regulatory Assoc.
Decision Date1996-08-01
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROSURGE ACUTRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Regulatory Assoc.. It received FDA 510(k) clearance on 1996-08-01 under 510(k) number K962770. The device is classified under product code KPN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROSURGE ACUTRAINER?

UROSURGE ACUTRAINER is a medical device that received FDA 510(k) clearance on 1996-08-01. The listed applicant is Princeton Regulatory Assoc.. The 510(k) number is K962770.

When did UROSURGE ACUTRAINER receive FDA 510(k) clearance?

UROSURGE ACUTRAINER received FDA 510(k) clearance on 1996-08-01, under 510(k) number K962770.

Who is the listed applicant for UROSURGE ACUTRAINER?

The FDA 510(k) record lists Princeton Regulatory Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROSURGE ACUTRAINER?

The FDA product code for UROSURGE ACUTRAINER is KPN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Princeton Regulatory Assoc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K965136UROSURGE UROTHERM FLUID WARMING SYSTEMK972158GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICESK973504UROSURGE UROSTENT

Related Devices (Code: KPN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130951SIMSimavita Pty LimitedK971442HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5Humed, Inc.K971855POTTY PAL AND FOREVER-DRYDigital Applications, Inc.K962416DRYTIME FOR BLADDER CONTROL SILENTBio-Systems ResearchK955338DRYTIME FOR POTTY TRAININGHealth Sense Intl., Inc.K943559REMOTE A'LERTHealth Sense Intl., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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