NON
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Forceps, Biopsy, Non-Electric, Reprocessed
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1075
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- FDA definition
- 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).
- Adverse events (MAUDE)
- 2012: 9 · 2016: 27
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 |
|---|---|---|
| REPROCESSED COLD BIOPSY FORCEPS (K042648) | Sterilmed, Inc. | 2005-07-20 |
| MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS (K042659) | Medisiss | 2005-02-14 |
| VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS (K042594) | Vanguard Medical Concepts, Inc. | 2005-01-25 |
Track NON automatically
Every clearance here is in the API, with alerts when new ones post.