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FDA 510(k)

SECURE-SITE

K-Number: K941098 · 1995-08-09

ApplicantOp-Co Medical Products , Ltd.
Decision Date1995-08-09
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SECURE-SITE is the device name listed in this FDA 510(k) record. The listed applicant is Op-Co Medical Products , Ltd.. It received FDA 510(k) clearance on 1995-08-09 under 510(k) number K941098. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECURE-SITE?

SECURE-SITE is a medical device that received FDA 510(k) clearance on 1995-08-09. The listed applicant is Op-Co Medical Products , Ltd.. The 510(k) number is K941098.

When did SECURE-SITE receive FDA 510(k) clearance?

SECURE-SITE received FDA 510(k) clearance on 1995-08-09, under 510(k) number K941098.

Who is the listed applicant for SECURE-SITE?

The FDA 510(k) record lists Op-Co Medical Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECURE-SITE?

The FDA product code for SECURE-SITE is KMK.

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 Op-Co Medical Products , Ltd. 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.

K932757SECURODRIP (TM) I.V. ARMBOARDK912660SECURODRIP

Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K981860A P HARNESSParaworks Enterprise, Ltd.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K943147STATLOCK CVVenetec, Inc.K943047IV START KITSSterile Concepts, Inc.K941850IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILETnt Moborg Intl. , Ltd.

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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