Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADVANCE MODEL UDS-ADV

K-Number: K931574 · 1993-08-05

ApplicantLaborie Medical Technologies, Ltd.
Decision Date1993-08-05
Product CodeEXQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADVANCE MODEL UDS-ADV is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Ltd.. It received FDA 510(k) clearance on 1993-08-05 under 510(k) number K931574. The device is classified under product code EXQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCE MODEL UDS-ADV?

ADVANCE MODEL UDS-ADV is a medical device that received FDA 510(k) clearance on 1993-08-05. The listed applicant is Laborie Medical Technologies, Ltd.. The 510(k) number is K931574.

When did ADVANCE MODEL UDS-ADV receive FDA 510(k) clearance?

ADVANCE MODEL UDS-ADV received FDA 510(k) clearance on 1993-08-05, under 510(k) number K931574.

Who is the listed applicant for ADVANCE MODEL UDS-ADV?

The FDA 510(k) record lists Laborie Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANCE MODEL UDS-ADV?

The FDA product code for ADVANCE MODEL UDS-ADV is EXQ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Laborie Medical Technologies, Ltd. 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.

K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPK962009UROSTYMK955856TEX-AID BLUEK955810U-TEXK951805PIPER, MODEL NUMBER UDS-PIPERBK942563ELITE BIOFEEDBACK

View all 11 devices →

Related Devices (Code: EXQ)

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.

K253537Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)Bright Uro, Inc.K243052Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))Bright Uro, Inc.K931282VOLUME TRANSDUCERLife-Tech Intl., Inc.K920574CAMSYS 6300F.M. Wiest USA, Inc.K880391DACOMED CYSTOMETERDacomed Corp.K812177LIFE-TECH #1857 PRESSURE/POLOT MODULELife-Tech Instruments, Inc.

Official Source

View on FDA Database →

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

↑