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)

UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)

K-Number: K971992 · 1997-08-01

ApplicantUromed Corp.
Decision Date1997-08-01
Product CodeFHA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) is the device name listed in this FDA 510(k) record. The listed applicant is Uromed Corp.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K971992. The device is classified under product code FHA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)?

UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Uromed Corp.. The 510(k) number is K971992.

When did UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) receive FDA 510(k) clearance?

UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) received FDA 510(k) clearance on 1997-08-01, under 510(k) number K971992.

Who is the listed applicant for UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)?

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

What is the FDA product code for UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)?

The FDA product code for UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) is FHA.

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 Uromed Corp. 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.

K010213MODIFICATION TO CAVERMAP SURGICAL AIDK010098MODIFICATION TO CAVERMAP SURGICAL AIDK000507CAVERMAP SURGICAL AIDK993436CAVERMAP SURGICAL AIDK982226UROMED BRACHYTHERAPHY IODINE-125 SOURCESK980717UROMED SLING KIT

View all 10 devices →

Related Devices (Code: FHA)

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.

K974040C3 EXTERNAL MALE BLADDER CONTROL DEVICETimm Research Co.K970308MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCEMentor Urology, Inc.K964580CAP-AID (IMPROVED)Nebel, Inc.K955810U-TEXLaborie Medical Technologies, Ltd.K954959CAP-AIDNebl, Inc.K952841THE ASSISTANTApple Medical Corp.

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.

↑