BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR— 510(k) K111648

Name: FDA 510(k) clearance K111648
Creator: U.S. Food and Drug Administration
Published: 2011-11-03

Substantially Equivalent

Bracco Diagnostic, Inc.

FDA 510(k) clearance K111648 for BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR, Substantially Equivalent on 2011-11-03. Applicant: Bracco Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Bracco Diagnostic, Inc.
Product code: Code FCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-13
Decision date: 2011-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K111648

K-number listed on FDA's recall record

Z-1148-2021 — Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.Class II·Terminated·Northgate Technologies, Inc.·20210115

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111648.

Data sourced from openFDA. This site is unofficial and independent of the FDA.