Dermatrix Duo— 510(k) K251836
Substantially EquivalentShenzhen Gsd Technology Co., Ltd.
FDA 510(k) clearance K251836 for Dermatrix Duo, Substantially Equivalent on 2026-02-06. Applicant: Shenzhen Gsd Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Gsd Technology's Dermatrix Duo is filed under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 878.4400. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Shenzhen Gsd Technology filed from Shenzhen, China. FDA found it substantially equivalent 235 calendar days after receipt (June 16, 2025 to February 6, 2026).
Clearance details
- Applicant
- Shenzhen Gsd Technology Co., 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
- Shenzhen, CN
Recent devices under product code GEI
view all- K262720 — SP Electrocautery Device (SP18 Max); SP Electrocautery Device (SP20 Max)
- K262386 — SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000) +1 more
- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K261959 — Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) +3 more
- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
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.