FDA product code NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
NBY is the FDA product code for suture, surgical, nonabsorbable, expanded, polytetraflouroethylene. It is a Class II device, regulated under 21 CFR 878.5035 and reviewed by the General and Plastic Surgery panel. FDA has cleared 17 510(k) submissions under NBY, 1 in the last five years, from 15 different applicants. The average 510(k) review took 139 days (median 118).
Classification
| Field | Value |
|---|---|
| Device name | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class II |
| Regulation | 21 CFR 878.5035 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NBY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 175 |
| 2018 | 4 | 86 |
| 2019 | 3 | 181 |
| 2023 | 1 | 190 |
Compare with all 510(k) review times · Search every NBY clearance
Top NBY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Omnia Spa | 2 | 2018-04-06 |
| Osteogenics Biomedical, Inc. | 2 | 2007-10-31 |
| Durastat, LLC | 1 | 2023-11-09 |
| Antarma, LLC Dba Golnit Sutures | 1 | 2019-09-04 |
| Purgo Biologics, Inc. | 1 | 2019-07-16 |
10 more applicants have NBY clearances. See the full list in Caduvo.
Most recent NBY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231277 | Durastat, LLC | TissueStat | 2023-11-09 | 190 |
| K192088 | Antarma, LLC Dba Golnit Sutures | GOLNIT Non-aborbable PTFE Surgical Suture | 2019-09-04 | 30 |
| K180992 | Purgo Biologics, Inc. | Biotex | 2019-07-16 | 456 |
| K191317 | Origami Surgical | StitchKit | 2019-07-12 | 58 |
| K181578 | Demetech Corporation | DemeTECH PTFE Nonabsorbable Surgical Suture | 2018-10-11 | 118 |
Recalls for NBY devices
openFDA lists no recalls for product code NBY.
Frequently asked questions
What is FDA product code NBY?
NBY is the FDA product code for suture, surgical, nonabsorbable, expanded, polytetraflouroethylene. It is a Class II device, regulated under 21 CFR 878.5035 and reviewed by the General and Plastic Surgery panel.
What device class is NBY?
Class II, regulation 21 CFR 878.5035. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBY?
Across 17 cleared submissions the average was 139 days from receipt to decision (median 118).
Which companies have the most NBY clearances?
Omnia Spa (2); Osteogenics Biomedical, Inc. (2); Durastat, LLC (1); Antarma, LLC Dba Golnit Sutures (1); Purgo Biologics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NBY
- Run a recall and safety report across every NBY manufacturer
- Watch product code NBY 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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