FCI
5 FDA 510(k) clearances · Product code
78 daysmedian time to decision
127 days90th percentile
5clearances measured
FDA profile
- Official device name
- Punch, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING (K895885) | National-Standard Co. | 1990-02-09 |
| BT-338N ELECTRONIC CLINICAL THERMOMETER (K894627) | Integrated Display Technology, Ltd. | 1989-10-23 |
| BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE (K875119) | Advanced Diagnostic Medical Systems, Inc. | 1988-03-02 |
| DISPOSABLE, STERILE BIOPSY PUNCH (K853104) | August C. Stiefel Research Institute, Inc. | 1985-10-04 |
| BIOPSY ATTACHMENT (K831317) | Diasonics, Inc. | 1983-05-18 |
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