NUJ · Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | NUJ |
|---|---|
| Device Name | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | Surgical Instrument Service and Savings, Inc. | Apr 29, 2024 | SESE |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Stryker Sustainability Solutions | Mar 28, 2023 | SESE |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Stryker Sustainability Solutions | May 13, 2022 | SESE |
| K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | Green Or, LLC | Apr 7, 2022 | SESE |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | Vein 360, LLC | Oct 22, 2019 | SESE |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | Oct 31, 2018 | SESE |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | Stryker Sustainability Solutions | Apr 23, 2018 | SESE |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | Apr 20, 2018 | SESE |
| K173214 | NES Reprocessed RF Stylet (RFS) | Northeast Scientific, Inc. (Nes) | Mar 27, 2018 | SESE |
| K173740 | Reprocessed DePuy Mitek Ablation Wand | Renovo, Inc. | Mar 19, 2018 | SESE |
| K173741 | Reprocessed ArthoCare Ablation Wand | Renovo, Inc. | Mar 5, 2018 | SESE |
| K172647 | Reprocessed ArthroCare ENT Coblator | Renovo, Inc. | Feb 21, 2018 | SESE |
| K172608 | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes | Surgical Instrument Service and Savings, Inc. | Oct 18, 2017 | SESE |
| K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics | Surgical Instrument Service and Savings, Inc. | Jun 23, 2017 | SESE |
| K162751 | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider | Surgical Instrument Services and Savings, Inc. | May 1, 2017 | SESE |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) | Sterilmed, Inc. | Sep 20, 2016 | SESE |
| K160333 | Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider | Surgical Instrument Service and Savings, Inc. | Jul 20, 2016 | SESE |
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | May 2, 2016 | SESE |
| K152134 | Reprocessed Vessel Sealer | Sterilmed, Inc. | Jan 15, 2016 | SESE |
| K152313 | Medline ReNewal Reprocessed Endopath Endoscopic Instruments | Surgical Instrument Services and Savings, Inc. | Jan 6, 2016 | SESE |
Top Applicants
- Stryker Sustainability Solutions — 7 clearances
- Sterilmed, Inc. — 7 clearances
- Surgical Instrument Service and Savings, Inc. — 4 clearances
- Suretek Medical — 3 clearances
- Renovo, Inc. — 3 clearances
