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FDA 510(k)

KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]

K-Number: K945949 · 1995-07-25

ApplicantVlm Surgical, Inc.
Decision Date1995-07-25
Product CodeHFX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] is the device name listed in this FDA 510(k) record. The listed applicant is Vlm Surgical, Inc.. It received FDA 510(k) clearance on 1995-07-25 under 510(k) number K945949. The device is classified under product code HFX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]?

KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] is a medical device that received FDA 510(k) clearance on 1995-07-25. The listed applicant is Vlm Surgical, Inc.. The 510(k) number is K945949.

When did KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] receive FDA 510(k) clearance?

KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] received FDA 510(k) clearance on 1995-07-25, under 510(k) number K945949.

Who is the listed applicant for KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]?

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

What is the FDA product code for KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]?

The FDA product code for KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] is HFX.

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 Vlm Surgical, 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.

K842912THE SUTURER

Related Devices (Code: HFX)

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.

K251687Konig Bell Circumcision ClampMedline Industries, LPK221356Wee BellWee MedicalK212911Konig Mogen ClampMedline Industries, Inc.K131373SHANGRINGWuhu Snnda Medical Treatment Appliance TechnologyK121789SHANGRINGWuhu Snna Medical Treatment Appliance Technology CK103695PREPEX SYSTEMCirc Medtech

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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