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FDA 510(k)

ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE

K-Number: K942427 · 1994-11-17

ApplicantEnvision Surgical System, Inc.
Decision Date1994-11-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Envision Surgical System, Inc.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K942427. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE?

ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Envision Surgical System, Inc.. The 510(k) number is K942427.

When did ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE receive FDA 510(k) clearance?

ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE received FDA 510(k) clearance on 1994-11-17, under 510(k) number K942427.

Who is the listed applicant for ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE?

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

What is the FDA product code for ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE?

The FDA product code for ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE is HRX.

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 Envision Surgical System, 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.

K943666ENVISION ARTHROSCOPY VISUALIZATION SYSTEMK942081ENVISION ARTHROSCOPY SYSTEM

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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