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FDA 510(k)

SUN MEDICAL LAMINARIA CERVICAL DILATOR

K-Number: K845006 · 1985-05-01

ApplicantSun Medical, Inc.
Decision Date1985-05-01
Product CodeHDY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SUN MEDICAL LAMINARIA CERVICAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sun Medical, Inc.. It received FDA 510(k) clearance on 1985-05-01 under 510(k) number K845006. 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 SUN MEDICAL LAMINARIA CERVICAL DILATOR?

SUN MEDICAL LAMINARIA CERVICAL DILATOR is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is Sun Medical, Inc.. The 510(k) number is K845006.

When did SUN MEDICAL LAMINARIA CERVICAL DILATOR receive FDA 510(k) clearance?

SUN MEDICAL LAMINARIA CERVICAL DILATOR received FDA 510(k) clearance on 1985-05-01, under 510(k) number K845006.

Who is the listed applicant for SUN MEDICAL LAMINARIA CERVICAL DILATOR?

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

What is the FDA product code for SUN MEDICAL LAMINARIA CERVICAL DILATOR?

The FDA product code for SUN MEDICAL LAMINARIA CERVICAL DILATOR 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

Other records listing Sun Medical, 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.

K921963DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900K911154SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200K874948SUN MEDICAL SMOKE EVACUATOR SYSTEM

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 MedevicesK881295LAMINARIA CUREXHarold W. Berger Co.

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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