Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sharpsite AC Rigid Endsocope

K-Number: K173855 · 2018-04-20

ApplicantMedtronic Xomed, Inc.
Decision Date2018-04-20
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sharpsite AC Rigid Endsocope is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K173855. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sharpsite AC Rigid Endsocope?

Sharpsite AC Rigid Endsocope is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K173855.

When did Sharpsite AC Rigid Endsocope receive FDA 510(k) clearance?

Sharpsite AC Rigid Endsocope received FDA 510(k) clearance on 2018-04-20, under 510(k) number K173855.

Who is the listed applicant for Sharpsite AC Rigid Endsocope?

The FDA 510(k) record lists Medtronic Xomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sharpsite AC Rigid Endsocope?

The FDA product code for Sharpsite AC Rigid Endsocope is EOB.

Other records listing Medtronic Xomed, 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.

K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeK231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongK210841NuVent Eustachian Tube Dilation BalloonK202623Novapak Nasal Sinus Packing and Stent

View all 8 devices →

Related Devices (Code: EOB)

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.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, Inc.

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.

↑