FDA product code NEW: Suture, Surgical, Absorbable, Polydioxanone
NEW is the FDA product code for suture, surgical, absorbable, polydioxanone. It is a Class II device, regulated under 21 CFR 878.4840 and reviewed by the General and Plastic Surgery panel. FDA has cleared 67 510(k) submissions under NEW, 16 in the last five years, from 38 different applicants. The average 510(k) review took 154 days (median 108); 173 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 40 recalls for NEW devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class II |
| Regulation | 21 CFR 878.4840 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NEW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 252 |
| 2018 | 3 | 357 |
| 2019 | 4 | 142 |
| 2020 | 3 | 259 |
| 2021 | 1 | 268 |
| 2022 | 1 | 204 |
| 2023 | 1 | 375 |
| 2024 | 3 | 116 |
| 2025 | 6 | 159 |
| 2026 | 5 | 243 |
Compare with all 510(k) review times · Search every NEW clearance
Top NEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 9 | 2026-05-18 |
| Surgical Specialties Corp | 5 | 2008-04-23 |
| Hans Biomed Corporation | 4 | 2026-09-18 |
| Feeltech Co., Ltd. | 3 | 2025-10-20 |
| Depuy Mitek | 3 | 2008-04-23 |
33 more applicants have NEW clearances. See the full list in Caduvo.
Most recent NEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254238 | Hans Biomed Corporation | MINT MONO Sutures | 2026-09-18 | 263 |
| K253879 | Samyang Holdings Corporation | MONOFIX PDO | 2026-08-25 | 264 |
| K261988 | Teleflex Medical, LLC | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | 2026-07-09 | 27 |
| K252171 | Sutura Medical Technology, Inc. | Barbed PDO Suture | 2026-06-12 | 337 |
| K252047 | ETHICON, Inc. | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | 2026-05-18 | 322 |
Recalls for NEW devices
40 product recalls in 22 recall events; 11 initiated in the last five years and 11 still open. Most recent: 2025-08-15.
| Year | Recalls |
|---|---|
| 2018 | 6 |
| 2019 | 7 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 5 |
Frequently asked questions
What is FDA product code NEW?
NEW is the FDA product code for suture, surgical, absorbable, polydioxanone. It is a Class II device, regulated under 21 CFR 878.4840 and reviewed by the General and Plastic Surgery panel.
What device class is NEW?
Class II, regulation 21 CFR 878.4840. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEW?
Across 67 cleared submissions the average was 154 days from receipt to decision (median 108).
Which companies have the most NEW clearances?
ETHICON, Inc. (9); Surgical Specialties Corp (5); Hans Biomed Corporation (4); Feeltech Co., Ltd. (3); Depuy Mitek (3).
Have NEW devices been recalled?
Yes: 40 product recalls across 22 recall events; the most recent began 2025-08-15.
Next steps
- Run an FDA pathway report with predicate devices for product code NEW
- Run a recall and safety report across every NEW manufacturer
- Watch product code NEW 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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