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FDA 510(k)

ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR

K-Number: K896196 · 1989-12-01

ApplicantOrthoconcept, Inc.
Decision Date1989-12-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR is the device name listed in this FDA 510(k) record. The listed applicant is Orthoconcept, Inc.. It received FDA 510(k) clearance on 1989-12-01 under 510(k) number K896196. 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 ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR?

ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR is a medical device that received FDA 510(k) clearance on 1989-12-01. The listed applicant is Orthoconcept, Inc.. The 510(k) number is K896196.

When did ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR receive FDA 510(k) clearance?

ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR received FDA 510(k) clearance on 1989-12-01, under 510(k) number K896196.

Who is the listed applicant for ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR?

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 ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR?

The FDA product code for ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR 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 PUMPK905785ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)K895643MODIFIED 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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