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FDA 510(k)

HYDROCISION ARTHROJET SYSTEM

K-Number: K982266 · 1998-09-25

ApplicantHydrocision, Inc.
Decision Date1998-09-25
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HYDROCISION ARTHROJET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hydrocision, Inc.. It received FDA 510(k) clearance on 1998-09-25 under 510(k) number K982266. 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 HYDROCISION ARTHROJET SYSTEM?

HYDROCISION ARTHROJET SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-25. The listed applicant is Hydrocision, Inc.. The 510(k) number is K982266.

When did HYDROCISION ARTHROJET SYSTEM receive FDA 510(k) clearance?

HYDROCISION ARTHROJET SYSTEM received FDA 510(k) clearance on 1998-09-25, under 510(k) number K982266.

Who is the listed applicant for HYDROCISION ARTHROJET SYSTEM?

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

What is the FDA product code for HYDROCISION ARTHROJET SYSTEM?

The FDA product code for HYDROCISION ARTHROJET SYSTEM is HRX.

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Other records listing Hydrocision, Inc. as applicant

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K241990SpineSite Endoscope SystemK200729HydroCision SpineJet SystemK190804HydroCision TenJet DeviceK041233ARTHROJET XTK032529HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310K021813HYDROCISION GENERAL SURGERY FLUIDJET 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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