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FDA 510(k)

HMT ALEXCOPE

K-Number: K941013 · 1995-02-09

ApplicantServicetrends, Inc.
Decision Date1995-02-09
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HMT ALEXCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Servicetrends, Inc.. It received FDA 510(k) clearance on 1995-02-09 under 510(k) number K941013. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HMT ALEXCOPE?

HMT ALEXCOPE is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Servicetrends, Inc.. The 510(k) number is K941013.

When did HMT ALEXCOPE receive FDA 510(k) clearance?

HMT ALEXCOPE received FDA 510(k) clearance on 1995-02-09, under 510(k) number K941013.

Who is the listed applicant for HMT ALEXCOPE?

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

What is the FDA product code for HMT ALEXCOPE?

The FDA product code for HMT ALEXCOPE is FGB.

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 Servicetrends, 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.

K942155HMT ENDOSCREEN, MODEL ESC 501K940461ALEXANTRIPTOR

Related Devices (Code: FGB)

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.

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific CorporationK262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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