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FDA 510(k)

FINE NEEDLE ASPIRATION DEVICE

K-Number: K841275 · 1984-08-17

ApplicantGyneco, Inc.
Decision Date1984-08-17
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FINE NEEDLE ASPIRATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Gyneco, Inc.. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K841275. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINE NEEDLE ASPIRATION DEVICE?

FINE NEEDLE ASPIRATION DEVICE is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Gyneco, Inc.. The 510(k) number is K841275.

When did FINE NEEDLE ASPIRATION DEVICE receive FDA 510(k) clearance?

FINE NEEDLE ASPIRATION DEVICE received FDA 510(k) clearance on 1984-08-17, under 510(k) number K841275.

Who is the listed applicant for FINE NEEDLE ASPIRATION DEVICE?

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

What is the FDA product code for FINE NEEDLE ASPIRATION DEVICE?

The FDA product code for FINE NEEDLE ASPIRATION DEVICE is DRM.

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 Gyneco, 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.

K861409SYNCARE TEMPORARY CARDIAC PACING WIREK853216MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4K852357GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIPK843941ENDOCYTE

Related Devices (Code: DRM)

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.

K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLCK173553LUCAS 3 Chest Compression SystemJolife ABK161768LUCAS 3 Chest Compression SystemJolife ABK153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLCK112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation

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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