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FDA 510(k)

ENVISION ARTHROSCOPY SYSTEM

K-Number: K942081 · 1994-11-09

ApplicantEnvision Surgical System, Inc.
Decision Date1994-11-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENVISION ARTHROSCOPY SYSTEM 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 1994-11-09 under 510(k) number K942081. 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 ARTHROSCOPY SYSTEM?

ENVISION ARTHROSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-09. The listed applicant is Envision Surgical System, Inc.. The 510(k) number is K942081.

When did ENVISION ARTHROSCOPY SYSTEM receive FDA 510(k) clearance?

ENVISION ARTHROSCOPY SYSTEM received FDA 510(k) clearance on 1994-11-09, under 510(k) number K942081.

Who is the listed applicant for ENVISION ARTHROSCOPY SYSTEM?

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 ARTHROSCOPY SYSTEM?

The FDA product code for ENVISION ARTHROSCOPY SYSTEM 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.

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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 SYSTEMK942427ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE

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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