FCI — Punch, Biopsy Class II
FDA product code FCI covers "Punch, Biopsy", a Class II medical device regulated under 21 CFR 876.1075. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCI
- 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 |
|---|---|---|---|
| K895885 | national-standard | AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING | February 9, 1990 |
| K894627 | integrated display technology | BT-338N ELECTRONIC CLINICAL THERMOMETER | October 23, 1989 |
| K875119 | advanced diagnostic medical systems | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE | March 2, 1988 |
| K853104 | august c. stiefel research institute | DISPOSABLE, STERILE BIOPSY PUNCH | October 4, 1985 |
| K831317 | diasonics | BIOPSY ATTACHMENT | May 18, 1983 |