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FDA 510(k)

ARTHROSCOPIC SURGICAL BLADE

K-Number: K904284 · 1990-12-05

ApplicantSmith & Nephew Dyonics, Inc.
Decision Date1990-12-05
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHROSCOPIC SURGICAL BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Dyonics, Inc.. It received FDA 510(k) clearance on 1990-12-05 under 510(k) number K904284. 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 ARTHROSCOPIC SURGICAL BLADE?

ARTHROSCOPIC SURGICAL BLADE is a medical device that received FDA 510(k) clearance on 1990-12-05. The listed applicant is Smith & Nephew Dyonics, Inc.. The 510(k) number is K904284.

When did ARTHROSCOPIC SURGICAL BLADE receive FDA 510(k) clearance?

ARTHROSCOPIC SURGICAL BLADE received FDA 510(k) clearance on 1990-12-05, under 510(k) number K904284.

Who is the listed applicant for ARTHROSCOPIC SURGICAL BLADE?

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

What is the FDA product code for ARTHROSCOPIC SURGICAL BLADE?

The FDA product code for ARTHROSCOPIC SURGICAL BLADE is HRX.

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Other records listing Smith & Nephew Dyonics, 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.

K955914LIMITED REUSE ARTHROSCOPIC BLADESK954627ECTRA II LIGAMENT RELEASE SYSTEMK954989DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADESK953695DYONICS DISPOSABLE ARTHROSCOPIC BLADESK953387ECTRA LIGAMENT RELEASE SYSTEMK945182DYONICS FIXATION SCREWS

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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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