NUJ — Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed Class II
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 |