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)

ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2

K-Number: K790519 · 1979-05-14

ApplicantAmerican Medical Systems, Inc.
Decision Date1979-05-14
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1979-05-14 under 510(k) number K790519. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2?

ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 is a medical device that received FDA 510(k) clearance on 1979-05-14. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K790519.

When did ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 receive FDA 510(k) clearance?

ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 received FDA 510(k) clearance on 1979-05-14, under 510(k) number K790519.

Who is the listed applicant for ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2?

The FDA 510(k) record lists American Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2?

The FDA product code for ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 is FAP.

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 American Medical Systems, Inc. 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.

K132655RETROARC RETROPUBIC SLING SYSTEMK112842AMS ELEVATE PCK100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191K092735GREENLIGHT XPS LASER SYSTEMK090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEMK090663AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

View all 72 devices →

Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., 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.

↑