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FDA 510(k)

3M FLUID IRRIGATION SYSTEM

K-Number: K941388 · 1994-10-07

Applicant3M Healthcare
Decision Date1994-10-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3M FLUID IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 1994-10-07 under 510(k) number K941388. 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 3M FLUID IRRIGATION SYSTEM?

3M FLUID IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is 3M Healthcare. The 510(k) number is K941388.

When did 3M FLUID IRRIGATION SYSTEM receive FDA 510(k) clearance?

3M FLUID IRRIGATION SYSTEM received FDA 510(k) clearance on 1994-10-07, under 510(k) number K941388.

Who is the listed applicant for 3M FLUID IRRIGATION SYSTEM?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M FLUID IRRIGATION SYSTEM?

The FDA product code for 3M FLUID IRRIGATION SYSTEM is HRX.

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Other records listing 3M Healthcare as applicant

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K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EK1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure MaskK1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face ShieldK1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance SystemK1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804SK153571Cavilon Advanced High Endurance Skin Protectant

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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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