New Deantronics Taiwan Ltd.
New Taipei City, TW
NEW DEANTRONICS TAIWAN LTD. appears in FDA device records in New Taipei City, TW. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for New Deantronics Taiwan Ltd. between 1998 and 2026. The busiest year on record is 1998, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 6 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 4 |
| 2020 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251492 | Irrigation Tubing Bipolar Cord Set | GEI | Substantially Equivalent | |
| K251899 | E Blator | GEI | Substantially Equivalent | |
| K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft | GEI | Substantially Equivalent | |
| K201221 | Electrosurgical Generator | GEI | Substantially Equivalent | |
| K200455 | Trigger Switch and Cord | GEI | Substantially Equivalent | |
| K193004 | Monopolar Cord | GEI | Substantially Equivalent | |
| K191064 | Argon Handset | GEI | Substantially Equivalent | |
| K183126 | Electrosurgical accessory | GEI | Substantially Equivalent | |
| K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J | GEI | Substantially Equivalent | |
| K180908 | Irrigation Tubing Bipolar Cord Set | GEI | Substantially Equivalent | |
| K170161 | New Deantronics E Green™ Electrosurgical Monopolar Pencils | GEI | Substantially Equivalent | |
| K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated | GEI | Substantially Equivalent | |
| K152031 | New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter. | GEI | Substantially Equivalent | |
| K982748 | BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224 | GEI | Substantially Equivalent | |
| K982749 | MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 | GEI | Substantially Equivalent | |
| K982746 | MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 | GEI | Substantially Equivalent | |
| K982743 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH | GEI | Substantially Equivalent | |
| K982742 | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH | GEI | Substantially Equivalent | |
| K982744 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681191 | 3008207730 | NEW DEANTRONICS TAIWAN LTD. | 12F. No.51, Sec. 4, Zhongyang Rd., New Taipei City 236 TW | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QGIAir-Handling Apparatus Accessory
- FYDApparatus, Exhaust, Surgical
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HRXArthroscope
- MKJAutomated External Defibrillators (Non-Wearable)
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- JOSElectrode, Electrosurgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GWGEndoscope, Neurological
- MDMInstrument, Manual, Surgical, General Use
- GCJLaparoscope, General & Plastic Surgery
- LXHOrthopedic Manual Surgical Instrument
- OSNSoftware For Diagnosis/Treatment
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain