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FDA 510(k)

AUKULYTE

K-Number: K953610 · 1995-09-26

ApplicantAukland Medical Plastics, Inc.
Decision Date1995-09-26
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AUKULYTE is the device name listed in this FDA 510(k) record. The listed applicant is Aukland Medical Plastics, Inc.. It received FDA 510(k) clearance on 1995-09-26 under 510(k) number K953610. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUKULYTE?

AUKULYTE is a medical device that received FDA 510(k) clearance on 1995-09-26. The listed applicant is Aukland Medical Plastics, Inc.. The 510(k) number is K953610.

When did AUKULYTE receive FDA 510(k) clearance?

AUKULYTE received FDA 510(k) clearance on 1995-09-26, under 510(k) number K953610.

Who is the listed applicant for AUKULYTE?

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

What is the FDA product code for AUKULYTE?

The FDA product code for AUKULYTE is KPY.

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 Aukland Medical Plastics, 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.

K930840POST-MYDS(TM)K930094AUKUSLEEVE

Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.K951003KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)Kenex , 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.

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