510(k) K111648 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
| Applicant | Bracco Diagnostic, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Nov 3, 2011 |
| Received | Jun 13, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2021 | Northgate Technologies, Inc. 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 Terminated |
FCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.