Panels › Gastroenterology, Urology › Product code FCI · Class 2
Punch, Biopsy
Regulation 876.1075
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FCI
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Diagnostic Medical Systems, Inc. | 1 | 0 |
| August C. Stiefel Research Institute, Inc. | 1 | 0 |
| Diasonics, Inc. | 1 | 0 |
| Integrated Display Technology, Ltd. | 1 | 0 |
| National-Standard Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 1990 | K895885 | AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING National-Standard Co. | FCI |
| Oct 23, 1989 | K894627 | BT-338N ELECTRONIC CLINICAL THERMOMETER Integrated Display Technology, Ltd., HK | FCI |
| Mar 2, 1988 | K875119 | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE Advanced Diagnostic Medical Systems, Inc. | FCI |
| Oct 4, 1985 | K853104 | DISPOSABLE, STERILE BIOPSY PUNCH August C. Stiefel Research Institute, Inc. | FCI |
| May 18, 1983 | K831317 | BIOPSY ATTACHMENT Diasonics, Inc. | FCI |
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