510(k) K910584 ยท KGC Tube, Gastro-Enterostomy
ONE STEP BUTTON(TM)
| Applicant | Applied Medical Technologies, Independence OH, US |
| Decision | Substantially Equivalent, May 23, 1991 |
| Received | Feb 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2015 | Boston Scientific Corp One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes) Kit, 18/2.4, pull; Catalog number 6314. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/2.4 pull; catalog number 6851. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/3.4 push; catalog number 6852. Terminated |
KGC | None listed |
| Jul 7, 2005 | Boston Scientific Corp Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/1.7 push; catalog number 6860. Terminated |
KGC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.