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FDA 510(k)

EDWARDS DISPOSABLE ARTHROSCOPY CANNULA

K-Number: K884301 · 1989-03-13

ApplicantBaxter Healthcare Corp
Decision Date1989-03-13
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EDWARDS DISPOSABLE ARTHROSCOPY CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-03-13 under 510(k) number K884301. 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 EDWARDS DISPOSABLE ARTHROSCOPY CANNULA?

EDWARDS DISPOSABLE ARTHROSCOPY CANNULA is a medical device that received FDA 510(k) clearance on 1989-03-13. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K884301.

When did EDWARDS DISPOSABLE ARTHROSCOPY CANNULA receive FDA 510(k) clearance?

EDWARDS DISPOSABLE ARTHROSCOPY CANNULA received FDA 510(k) clearance on 1989-03-13, under 510(k) number K884301.

Who is the listed applicant for EDWARDS DISPOSABLE ARTHROSCOPY CANNULA?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDWARDS DISPOSABLE ARTHROSCOPY CANNULA?

The FDA product code for EDWARDS DISPOSABLE ARTHROSCOPY CANNULA is HRX.

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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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