gi-4000 Electrosurgical Generator— 510(k) K192265
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K192265 for gi-4000 Electrosurgical Generator, Substantially Equivalent on 2020-05-21. Applicant: United States Endoscopy Group, Inc.. Device class: 2.
Clearance details
- Applicant
- United States Endoscopy Group, Inc.
- 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
- Mentor, OH, US
Recent devices under product code GEI
view allMore clearances from United States Endoscopy Group, Inc.
view all- K200745 — Lariat, Hot/Cold Snare
- K192059 — Bio Guard Air/Water & Suction Valves
- K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
- K182909 — Roth Net Retriever Product Line
- K182258 — AquaShield System CO2; AquaShield System CO2 - PENTAX; AquaShield System CO2 - Fujifilm
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 →
Recalls naming K192265
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192265.
Data sourced from openFDA. This site is unofficial and independent of the FDA.