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)

AdvanCE capsule endoscope delivery device

K-Number: K163495 · 2017-03-10

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2017-03-10
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AdvanCE capsule endoscope delivery device is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K163495. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AdvanCE capsule endoscope delivery device?

AdvanCE capsule endoscope delivery device is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K163495.

When did AdvanCE capsule endoscope delivery device receive FDA 510(k) clearance?

AdvanCE capsule endoscope delivery device received FDA 510(k) clearance on 2017-03-10, under 510(k) number K163495.

Who is the listed applicant for AdvanCE capsule endoscope delivery device?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdvanCE capsule endoscope delivery device?

The FDA product code for AdvanCE capsule endoscope delivery device is NEZ.

Other records listing United States Endoscopy Group, 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.

K192265gi-4000 Electrosurgical GeneratorK200745Lariat, Hot/Cold SnareK192059Bio Guard Air/Water & Suction ValvesK191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMK182909Roth Net Retriever Product LineK182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm

View all 10 devices →

Related Devices (Code: NEZ)

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.

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)

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.

↑