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FDA 510(k)

Smith+Nephew Arthroscopes

K-Number: K201349 · 2020-07-20

ApplicantSmith & Nephew
Decision Date2020-07-20
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Smith+Nephew Arthroscopes is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K201349. 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 Arthroscopes?

Smith+Nephew Arthroscopes is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Smith & Nephew. The 510(k) number is K201349.

When did Smith+Nephew Arthroscopes receive FDA 510(k) clearance?

Smith+Nephew Arthroscopes received FDA 510(k) clearance on 2020-07-20, under 510(k) number K201349.

Who is the listed applicant for Smith+Nephew Arthroscopes?

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

What is the FDA product code for Smith+Nephew Arthroscopes?

The FDA product code for Smith+Nephew Arthroscopes is HRX.

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Other records listing Smith & Nephew 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.

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC GlenoidsPMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesisK252416AETOS Shoulder System Meta Humeral Prosthesis Size 0K252129AETOS Shoulder System Stemless Humeral ProsthesisK251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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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.

K252790Digital 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)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC

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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