New Deantronics Taiwan , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 18
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251899 | E Blator | October 1, 2025 |
| K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, No | November 20, 2020 |
| K201221 | Electrosurgical Generator | September 28, 2020 |
| K200455 | Trigger Switch and Cord | March 31, 2020 |
| K193004 | Monopolar Cord | December 19, 2019 |
| K191064 | Argon Handset | June 12, 2019 |
| K183126 | Electrosurgical accessory | May 8, 2019 |
| K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook | February 19, 2019 |
| K180908 | Irrigation Tubing Bipolar Cord Set | May 18, 2018 |
| K170161 | New Deantronics E Green Electrosurgical Monopolar Pencils | March 29, 2017 |
| K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated | January 5, 2016 |
| K152031 | New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapt | September 17, 2015 |
| K982748 | BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224 | November 3, 1998 |
| K982743 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 | September 14, 1998 |
| K982742 | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, S | September 14, 1998 |
| K982749 | MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 | September 14, 1998 |
| K982746 | MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 | September 14, 1998 |
| K982744 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB | September 11, 1998 |