FDA product code NUJ: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
NUJ is the FDA product code for electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 37 510(k) submissions under NUJ, 4 in the last five years, from 15 different applicants. The average 510(k) review took 149 days (median 140); 255 days on average over the last three years. FDA has posted 20 recalls for NUJ devices, 17 initiated in the last five years.
Definition
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 | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for NUJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 103 |
| 2018 | 7 | 99 |
| 2019 | 1 | 183 |
| 2022 | 2 | 219 |
| 2023 | 1 | 57 |
| 2024 | 1 | 255 |
Compare with all 510(k) review times · Search every NUJ clearance
Top NUJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Sustainability Solutions | 7 | 2023-03-28 |
| Sterilmed, Inc. | 7 | 2016-09-20 |
| Surgical Instrument Service and Savings, Inc. | 4 | 2024-04-29 |
| Renovo, Inc. | 3 | 2018-03-19 |
| Suretek Medical | 3 | 2006-05-12 |
10 more applicants have NUJ clearances. See the full list in Caduvo.
Most recent NUJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232511 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | 2024-04-29 | 255 |
| K230251 | Stryker Sustainability Solutions | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | 2023-03-28 | 57 |
| K220411 | Stryker Sustainability Solutions | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | 2022-05-13 | 88 |
| K211203 | Green Or, LLC | Green OR Reprocessed Aquamantys Bipolar Sealer | 2022-04-07 | 350 |
| K191073 | Vein 360, LLC | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | 2019-10-22 | 183 |
Recalls for NUJ devices
20 product recalls in 5 recall events; 17 initiated in the last five years and 17 still open. Most recent: 2025-10-01.
| Year | Recalls |
|---|---|
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 11 |
Frequently asked questions
What is FDA product code NUJ?
NUJ is the FDA product code for electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is NUJ?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUJ?
Across 37 cleared submissions the average was 149 days from receipt to decision (median 140).
Which companies have the most NUJ clearances?
Stryker Sustainability Solutions (7); Sterilmed, Inc. (7); Surgical Instrument Service and Savings, Inc. (4); Renovo, Inc. (3); Suretek Medical (3).
Have NUJ devices been recalled?
Yes: 20 product recalls across 5 recall events; the most recent began 2025-10-01.
Next steps
- Run an FDA pathway report with predicate devices for product code NUJ
- Run a recall and safety report across every NUJ manufacturer
- Watch product code NUJ 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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