Snowden-Pencer MicroLap 3mm Laparoscopic Instruments— 510(k) K163615
Substantially EquivalentCarefusion 2200, Inc.
FDA 510(k) clearance K163615 for Snowden-Pencer MicroLap 3mm Laparoscopic Instruments, Substantially Equivalent on 2017-05-04. Applicant: Carefusion 2200, Inc.. Device class: 2.
Clearance details
- Applicant
- Carefusion 2200, 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
- Vernon Hills, IL, US
Recent devices under product code GEI
view allMore clearances from Carefusion 2200, Inc.
view all- K210324 — V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
- K162432 — Multi-Link X2 ECG Cable and Lead Wire System
- K160764 — AirLife Autofill Humidification Chamber
- K153554 — Genesis Low Temperature Reusable Rigid Container System
- K151036 — Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
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.