NUJ — Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed Class II
FDA product code NUJ covers "Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NUJ
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232511 | surgical instrument service and savings | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | April 29, 2024 |
| K230251 | stryker sustainability solutions | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | March 28, 2023 |
| K220411 | stryker sustainability solutions | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | May 13, 2022 |
| K211203 | green or | Green OR Reprocessed Aquamantys Bipolar Sealer | April 7, 2022 |
| K191073 | vein 360 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | October 22, 2019 |
| K182588 | surgical instrument service and savings inc.(dba medline ren | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider | October 31, 2018 |
| K180499 | stryker sustainability solutions | Reprocessed LigaSure Maryland Jaw Sealer/Divider | April 23, 2018 |
| K180451 | stryker sustainability solutions | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | April 20, 2018 |
| K173214 | northeast scientific, inc. (nes) | NES Reprocessed RF Stylet (RFS) | March 27, 2018 |
| K173740 | renovo | Reprocessed DePuy Mitek Ablation Wand | March 19, 2018 |
| K173741 | renovo | Reprocessed ArthoCare Ablation Wand | March 5, 2018 |
| K172647 | renovo | Reprocessed ArthroCare ENT Coblator | February 21, 2018 |
| K172608 | surgical instrument service and savings | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes | October 18, 2017 |
| K171324 | surgical instrument service and savings | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics | June 23, 2017 |
| K162751 | surgical instrument services and savings | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider | May 1, 2017 |
| K161086 | sterilmed | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed | September 20, 2016 |
| K160333 | surgical instrument service and savings | Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider | July 20, 2016 |
| K153745 | surgical instrument service and savings inc.(dba medline ren | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider | May 2, 2016 |
| K152134 | sterilmed | Reprocessed Vessel Sealer | January 15, 2016 |
| K152313 | surgical instrument services and savings | Medline ReNewal Reprocessed Endopath Endoscopic Instruments | January 6, 2016 |