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FDA 510(k)

TRT (ACUSON) NEEDLE GUIDE KIT, STERILE

K-Number: K892068 · 1989-08-04

ApplicantAmedic USA
Decision Date1989-08-04
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRT (ACUSON) NEEDLE GUIDE KIT, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Amedic USA. It received FDA 510(k) clearance on 1989-08-04 under 510(k) number K892068. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRT (ACUSON) NEEDLE GUIDE KIT, STERILE?

TRT (ACUSON) NEEDLE GUIDE KIT, STERILE is a medical device that received FDA 510(k) clearance on 1989-08-04. The listed applicant is Amedic USA. The 510(k) number is K892068.

When did TRT (ACUSON) NEEDLE GUIDE KIT, STERILE receive FDA 510(k) clearance?

TRT (ACUSON) NEEDLE GUIDE KIT, STERILE received FDA 510(k) clearance on 1989-08-04, under 510(k) number K892068.

Who is the listed applicant for TRT (ACUSON) NEEDLE GUIDE KIT, STERILE?

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

What is the FDA product code for TRT (ACUSON) NEEDLE GUIDE KIT, STERILE?

The FDA product code for TRT (ACUSON) NEEDLE GUIDE KIT, STERILE is FCG.

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 Amedic USA 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.

K897120EQUIP COVERS, STERILEK892070GENERAL IVT NEEDLE GUIDE KIT, STERILEK892069EXTENDED COVERS, STERILEK892071GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILEK871467BIOPSY NEEDLE GUIDE KIT, STERILEK871565ULTRASOUND TRANSDUCER GEL, STERILE

View all 10 devices →

Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, 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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