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FDA 510(k)

SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS

K-Number: K050580 · 2005-04-20

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date2005-04-20
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 2005-04-20 under 510(k) number K050580. 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 SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS?

SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-04-20. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K050580.

When did SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS receive FDA 510(k) clearance?

SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS received FDA 510(k) clearance on 2005-04-20, under 510(k) number K050580.

Who is the listed applicant for SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS?

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

What is the FDA product code for SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS?

The FDA product code for SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS is HRX.

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Other records listing Smith & Nephew Endoscopy, 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.

K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSK102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORSK093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORK083226SMITH & NEPHEW PEEK INTERFERENCE SCREWK083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWK082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

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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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