Irrigation Tubing Bipolar Cord Set— 510(k) K251492
Substantially EquivalentNew Deantronics Taiwan , Ltd.
FDA 510(k) clearance K251492 for Irrigation Tubing Bipolar Cord Set, Substantially Equivalent on 2026-06-29. Applicant: New Deantronics Taiwan , Ltd.. Device class: 2.
Clearance details
- Applicant
- New Deantronics Taiwan , Ltd.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
Recent devices under product code GEI
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view all- K251899 — E Blator
- 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
- K201221 — Electrosurgical Generator
- K200455 — Trigger Switch and Cord
- K193004 — Monopolar Cord
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.