NBYClass II
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
21 CFR 878.5035 / General, Plastic Surgery
NBY is the FDA product code for Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, a class II device type, regulated under 21 CFR 878.5035. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NBY
- Device name
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Regulation
- 21 CFR 878.5035
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 17
- Ingested recalls
- 0
Clearances, product code NBY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2007 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 3 |
| 2023 | 1 |
Applicants with the most clearances
Product code NBY| Applicant | Clearances |
|---|---|
| ORIGAMI SURGICAL Inc. | 2 |
| Osteogenics Biomedical, Inc. | 2 |
| Antarma dba Golnit Sutures | 1 |
| Antarma, LLC dba Golnit Sutures | 1 |
| Cp Medical | 1 |
| Demetech Corp. | 1 |
| Dura Tap, LLC | 1 |
| DuraStat | 1 |
| Foosin Medical Supplies Inc., Ltd. | 1 |
| Lsi Solutions Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.