Company ยท US
Omnitech Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2016. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 27, 2016 | K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode Omnitech Systems, Inc. | FAS |
| May 27, 2005 | K050454 | OMNITECH FULGURATING ELECTRODE Omnitech Systems, Inc. | FAS |
| Jul 17, 1998 | K981463 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE Omnitech Systems, Inc. | KNF |
| Jul 10, 1998 | K981464 | OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE Omnitech Systems, Inc. | KNF |
| Apr 22, 1997 | K964365 | RESECTOSCOPE CUTTING LOOP ELECTRODE Omnitech Systems, Inc. | FAS |
| Mar 19, 1997 | K965093 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE Omnitech Systems, Inc. | FAS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||