510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111648Substantially Equivalent

Bracco Diagnostics, Inc. Co2mpact Endodcopic Insufflator

Bracco Diagnostic, Inc., Melville NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111648 is the FDA 510(k) clearance record for BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR, a class II device, cleared for Bracco Diagnostic, Inc. on under FDA product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope). FDA records list 3 510(k) clearances for Bracco Diagnostic, Inc., from to . As of , FDA records show one recall naming K111648.

Clearance record

Decision date
Received
(143 days to decision)
Product code
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bracco Diagnostic, Inc. 532 Broadhollow Rd., Melville NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCX

Trailing 12 months
1 clearance under product code FCX in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260