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FDA 510(k)

BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM

K-Number: K091958 · 2010-04-30

ApplicantGlenveigh Surgical, LLC
Decision Date2010-04-30
Product CodeOQY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM 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 2010-04-30 under 510(k) number K091958. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM?

BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Glenveigh Surgical, LLC. The 510(k) number is K091958.

When did BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM receive FDA 510(k) clearance?

BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM received FDA 510(k) clearance on 2010-04-30, under 510(k) number K091958.

Who is the listed applicant for BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM?

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 BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM?

The FDA product code for BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM is OQY.

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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.

K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER

Related Devices (Code: OQY)

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.

K253642Jada System (Jada-2002)Organon, LLCK230849ELLAVI UBTSinapi Biomedical (Pty) , Ltd.K223098Bakri Essential Postpartum BalloonCook IncorporatedK212757Jada SystemAlydia HealthK201199Jada SystemAlydia HealthK191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust

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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