DIAMOND-FLEX(R) GRASPERS— 510(k) K110257
Substantially EquivalentCarefusion 2200, Inc.
FDA 510(k) clearance K110257 for DIAMOND-FLEX(R) GRASPERS, Substantially Equivalent on 2011-05-06. Applicant: Carefusion 2200, Inc.. Device class: 2.
Clearance details
- Applicant
- Carefusion 2200, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code GCJ
view allMore clearances from Carefusion 2200, Inc.
view all- K210324 — V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
- K163615 — Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
- K162432 — Multi-Link X2 ECG Cable and Lead Wire System
- K160764 — AirLife Autofill Humidification Chamber
- K153554 — Genesis Low Temperature Reusable Rigid Container System
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.