FCF — Instrument, Biopsy, Mechanical, Gastrointestinal Class II
FDA product code FCF covers "Instrument, Biopsy, Mechanical, Gastrointestinal", a Class II medical device regulated under 21 CFR 876.1075. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCF
- Device Class
- Class II
- Regulation Number
- 876.1075
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070759 | vidacare corporation | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM | May 21, 2007 |
| K062833 | vidacare corporation | POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM | November 30, 2006 |
| K984168 | united states endoscopy group | BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE | December 7, 1999 |
| K915142 | intl. medical | AMCATH DISPOSABLE BIOPSY FORCEPS | January 10, 1992 |
| K911155 | endovations | OVAL CUP BIOPSY FORCEP | August 7, 1991 |
| K843477 | zimmar consulting | PHARMA-PLAST RECTAL TIP | December 5, 1984 |