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FDA 510(k)

ORTHOCONCEPT ARTHROSCOPIC PUMP

K-Number: K910164 · 1991-03-27

ApplicantOrthoconcept, Inc.
Decision Date1991-03-27
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOCONCEPT ARTHROSCOPIC PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Orthoconcept, Inc.. It received FDA 510(k) clearance on 1991-03-27 under 510(k) number K910164. 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 ORTHOCONCEPT ARTHROSCOPIC PUMP?

ORTHOCONCEPT ARTHROSCOPIC PUMP is a medical device that received FDA 510(k) clearance on 1991-03-27. The listed applicant is Orthoconcept, Inc.. The 510(k) number is K910164.

When did ORTHOCONCEPT ARTHROSCOPIC PUMP receive FDA 510(k) clearance?

ORTHOCONCEPT ARTHROSCOPIC PUMP received FDA 510(k) clearance on 1991-03-27, under 510(k) number K910164.

Who is the listed applicant for ORTHOCONCEPT ARTHROSCOPIC PUMP?

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 ORTHOCONCEPT ARTHROSCOPIC PUMP?

The FDA product code for ORTHOCONCEPT ARTHROSCOPIC PUMP 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 4K905785ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)K896196ARTHROSCOPY 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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