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FDA 510(k)

IRRIGATION SET

K-Number: K883300 · 1988-11-01

ApplicantEdwards Orthopaedics Div., Baxter Healthcare Corp.
Decision Date1988-11-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IRRIGATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Orthopaedics Div., Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1988-11-01 under 510(k) number K883300. 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 IRRIGATION SET?

IRRIGATION SET is a medical device that received FDA 510(k) clearance on 1988-11-01. The listed applicant is Edwards Orthopaedics Div., Baxter Healthcare Corp.. The 510(k) number is K883300.

When did IRRIGATION SET receive FDA 510(k) clearance?

IRRIGATION SET received FDA 510(k) clearance on 1988-11-01, under 510(k) number K883300.

Who is the listed applicant for IRRIGATION SET?

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

What is the FDA product code for IRRIGATION SET?

The FDA product code for IRRIGATION SET is HRX.

Related Clinical Trials

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.

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Other records listing Edwards Orthopaedics Div., Baxter Healthcare Corp. 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.

K883299SUTURE RETENTION DEVICE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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