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FDA 510(k)

ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)

K-Number: K905785 · 1991-03-26

ApplicantOrthoconcept, Inc.
Decision Date1991-03-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) is the device name listed in this FDA 510(k) record. The listed applicant is Orthoconcept, Inc.. It received FDA 510(k) clearance on 1991-03-26 under 510(k) number K905785. 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 ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)?

ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) is a medical device that received FDA 510(k) clearance on 1991-03-26. The listed applicant is Orthoconcept, Inc.. The 510(k) number is K905785.

When did ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) receive FDA 510(k) clearance?

ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) received FDA 510(k) clearance on 1991-03-26, under 510(k) number K905785.

Who is the listed applicant for ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)?

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

What is the FDA product code for ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)?

The FDA product code for ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) is HRX.

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Other records listing Orthoconcept, 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.

K925160ARTHRO FMS 4K910164ORTHOCONCEPT ARTHROSCOPIC PUMPK896196ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHARK895643MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEMK894363UROPUMP* FLUID MANAGEMENT SYSTEMK882469CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES

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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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