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FDA 510(k)

INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)

K-Number: K892376 · 1989-08-01

ApplicantConcept, Inc.
Decision Date1989-08-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1989-08-01 under 510(k) number K892376. 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 INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)?

INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) is a medical device that received FDA 510(k) clearance on 1989-08-01. The listed applicant is Concept, Inc.. The 510(k) number is K892376.

When did INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) receive FDA 510(k) clearance?

INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) received FDA 510(k) clearance on 1989-08-01, under 510(k) number K892376.

Who is the listed applicant for INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)?

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

What is the FDA product code for INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)?

The FDA product code for INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) is HRX.

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Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBEK881954CONCEPT POWER SYSTEM

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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

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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