Nes Reprocessed Varicose Vein RF Catheter
FDA 510(k) K090661 · Northeast Scientific, Inc.
510(k) numberK090661
Submission
- Device name
- Nes Reprocessed Varicose Vein RF Catheter
- Applicant
- Northeast Scientific, Inc.
Waterbury, CT, US - Received
- March 12, 2009
- Decision date
- July 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUJ – Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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).
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| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Traditional | Stryker Sustainability Solutions | 05/13/2022SE |
| K211203 | Green OR Reprocessed Aquamantys Bipolar SealerNUJ · Traditional | Green Or, LLC | 04/07/2022SE |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterNUJ · Traditional | Vein 360, LLC | 10/22/2019SE |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 10/31/2018SE |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | Stryker Sustainability Solutions | 04/23/2018SE |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/DividerNUJ · Traditional | Stryker Sustainability Solutions | 04/20/2018SE |
| K173214 | NES Reprocessed RF Stylet (RFS)NUJ · Traditional | Northeast Scientific, Inc. (Nes) | 03/27/2018SE |
| K173740 | Reprocessed DePuy Mitek Ablation WandNUJ · Traditional | Renovo, Inc. | 03/19/2018SE |
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| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)OWQ · Traditional | 05/12/2025SE |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterOWQ · Traditional | 02/03/2023SE |
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterQTF · Traditional | 07/01/2022SE |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS CatheterOBJ · Traditional | 06/22/2020SE |
| K060676 | Nes Reprocessed Endoscopic TrocarNLM · Traditional | 09/07/2007SE |
Questions and answers
When was Nes Reprocessed Varicose Vein RF Catheter cleared by the FDA?
Nes Reprocessed Varicose Vein RF Catheter (K090661) received a 510(k) decision of Substantially Equivalent on July 21, 2010, 496 days after the submission was received.
What is the product code of K090661?
The FDA product code is NUJ – Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 878.4400.