SUCTION IRRIGATION ELECTRODES AND ADAPTERS— 510(k) K100711
Substantially EquivalentEncision, Inc.
FDA 510(k) clearance K100711 for SUCTION IRRIGATION ELECTRODES AND ADAPTERS, Substantially Equivalent on 2010-06-09. Applicant: Encision, Inc.. Device class: 2.
Clearance details
- Applicant
- Encision, 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
- Boulder, CO, US
Recent devices under product code GEI
view allMore clearances from Encision, Inc.
view all- K201018 — Encision AEM enTouch 2X Scissor
- K140006 — ENDOSHIELD BURN PROTECTION SYSTEM
- K131949 — AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
- K122383 — EM3 AEM MONITOR AEM CONNECTORS
- K122580 — AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES
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.