Forceps, Biopsy, Non-Electric, Reprocessed
FDA product code NON · Class I (low risk) · 21 CFR 876.1075 · Gastroenterology, Urology
same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
3510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042648 | Reprocessed Cold Biopsy ForcepsNON · Traditional | Sterilmed, Inc. | 07/20/2005SE |
| K042659 | Medisiss Reprocessed Non-Electric Gi Biopsy ForcepsNON · Traditional | Medisiss | 02/14/2005SE |
| K042594 | Vanguard Reprocessed Non-Electric Biopsy ForcepsNON · Traditional | Vanguard Medical Concepts, Inc. | 01/25/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0575-2009 | Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |