FDA product code NON: Forceps, Biopsy, Non-Electric, Reprocessed
NON is the FDA product code for forceps, biopsy, non-electric, reprocessed. It is a Class I device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under NON, from 3 different applicants. The average 510(k) review took 186 days (median 139). FDA has posted 1 recall for NON devices.
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).
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Biopsy, Non-Electric, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 876.1075 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NON clearance
Top NON applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 1 | 2005-07-20 |
| Medisiss | 1 | 2005-02-14 |
| Vanguard Medical Concepts, Inc. | 1 | 2005-01-25 |
Most recent NON clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042648 | Sterilmed, Inc. | REPROCESSED COLD BIOPSY FORCEPS | 2005-07-20 | 295 |
| K042659 | Medisiss | MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS | 2005-02-14 | 139 |
| K042594 | Vanguard Medical Concepts, Inc. | VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS | 2005-01-25 | 124 |
Recalls for NON devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-08.
Frequently asked questions
What is FDA product code NON?
NON is the FDA product code for forceps, biopsy, non-electric, reprocessed. It is a Class I device, regulated under 21 CFR 876.1075 and reviewed by the Gastroenterology and Urology panel.
What device class is NON?
Class I, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
How long does a 510(k) take for product code NON?
Across 3 cleared submissions the average was 186 days from receipt to decision (median 139).
Which companies have the most NON clearances?
Sterilmed, Inc. (1); Medisiss (1); Vanguard Medical Concepts, Inc. (1).
Have NON devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-08-08.
Next steps
- Run an FDA pathway report with predicate devices for product code NON
- Run a recall and safety report across every NON manufacturer
- Watch product code NON for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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