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)

LAMINARIA CUREX

K-Number: K881295 · 1988-08-10

ApplicantHarold W. Berger Co.
Decision Date1988-08-10
Product CodeHDY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAMINARIA CUREX is the device name listed in this FDA 510(k) record. The listed applicant is Harold W. Berger Co.. It received FDA 510(k) clearance on 1988-08-10 under 510(k) number K881295. The device is classified under product code HDY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMINARIA CUREX?

LAMINARIA CUREX is a medical device that received FDA 510(k) clearance on 1988-08-10. The listed applicant is Harold W. Berger Co.. The 510(k) number is K881295.

When did LAMINARIA CUREX receive FDA 510(k) clearance?

LAMINARIA CUREX received FDA 510(k) clearance on 1988-08-10, under 510(k) number K881295.

Who is the listed applicant for LAMINARIA CUREX?

The FDA 510(k) record lists Harold W. Berger Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAMINARIA CUREX?

The FDA product code for LAMINARIA CUREX is HDY.

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

Related Devices (Code: HDY)

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.

K040625ATAD ARD CATHETERAtad Developments , Ltd.K021012LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLCK011512MMODIFICATION TO LAMINARIAA & A Medical, Inc.K955072LAMINARIACti Corp., Ltd.K892220LAMINARIA TENTBerkeley MedevicesK881312LAMINARIABusse Hospital Disposables, Inc.

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.

↑