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.
Summary
New Deantronics Taiwan's Irrigation Tubing Bipolar Cord Set is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The name is generic, and the record gives no model numbers or description.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
New Deantronics filed from New Taipei City, Taiwan. Review took 410 calendar days (May 15, 2025 to June 29, 2026).
Clearance details
- Applicant
- New Deantronics Taiwan , Ltd.
- Product code
- Product 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
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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.