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FDA 510(k)

CONCEPT INTRAVISION ARTHROSCOPE SYSTEM

K-Number: K863396 · 1986-09-12

ApplicantConcept, Inc.
Decision Date1986-09-12
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONCEPT INTRAVISION ARTHROSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1986-09-12 under 510(k) number K863396. 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 CONCEPT INTRAVISION ARTHROSCOPE SYSTEM?

CONCEPT INTRAVISION ARTHROSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1986-09-12. The listed applicant is Concept, Inc.. The 510(k) number is K863396.

When did CONCEPT INTRAVISION ARTHROSCOPE SYSTEM receive FDA 510(k) clearance?

CONCEPT INTRAVISION ARTHROSCOPE SYSTEM received FDA 510(k) clearance on 1986-09-12, under 510(k) number K863396.

Who is the listed applicant for CONCEPT INTRAVISION ARTHROSCOPE SYSTEM?

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 CONCEPT INTRAVISION ARTHROSCOPE SYSTEM?

The FDA product code for CONCEPT INTRAVISION ARTHROSCOPE SYSTEM 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 SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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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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