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)

GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER

K-Number: K093904 · 2010-04-14

ApplicantGlenveigh Surgical, LLC
Decision Date2010-04-14
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Glenveigh Surgical, LLC. It received FDA 510(k) clearance on 2010-04-14 under 510(k) number K093904. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER?

GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2010-04-14. The listed applicant is Glenveigh Surgical, LLC. The 510(k) number is K093904.

When did GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER receive FDA 510(k) clearance?

GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER received FDA 510(k) clearance on 2010-04-14, under 510(k) number K093904.

Who is the listed applicant for GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER?

The FDA 510(k) record lists Glenveigh Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER?

The FDA product code for GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER is KNA.

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 Glenveigh Surgical, LLC 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.

K091958BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM

Related Devices (Code: KNA)

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/GynK014248DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVERUrogyn , Ltd.

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.

↑