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)

BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR

K-Number: K111648 · 2011-11-03

ApplicantBracco Diagnostic, Inc.
Decision Date2011-11-03
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bracco Diagnostic, Inc.. It received FDA 510(k) clearance on 2011-11-03 under 510(k) number K111648. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR?

BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR is a medical device that received FDA 510(k) clearance on 2011-11-03. The listed applicant is Bracco Diagnostic, Inc.. The 510(k) number is K111648.

When did BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR receive FDA 510(k) clearance?

BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR received FDA 510(k) clearance on 2011-11-03, under 510(k) number K111648.

Who is the listed applicant for BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR?

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

What is the FDA product code for BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR?

The FDA product code for BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR is FCX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bracco Diagnostic, 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.

K123047BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET

Related Devices (Code: FCX)

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.

K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.K230474EVA5 InsufflatorPalliare , Ltd.K202922END 200 Endoscopic TubesetPalliare , Ltd.K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, 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.

↑