510(k) K120151 ยท HIF Insufflator, Laparoscopic
NEBULAE I
| Applicant | Northgate Technologies, Inc., Elgin IL, US |
| Decision | Substantially Equivalent, Aug 17, 2012 |
| Received | Jan 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120151
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2021 | Northgate Technologies, Inc. ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical ins Terminated |
HIF | None listed |
| Nov 21, 2016 | Northgate Technologies, Inc. Insufflator, laparoscopic
The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operati Terminated |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.