Home / 510(k) Clearances / K090661

510(k) K090661

NES REPROCESSED VARICOSE VEIN RF CATHETER by Northeast Scientific, Inc. — Product Code NUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2010
Date Received
March 12, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

Other clearances by Northeast Scientific, Inc.

  • K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (May 12, 2025)
  • K223026 — NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (February 3, 2023)
  • K220171 — NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (July 1, 2022)
  • K200195 — NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (June 22, 2020)
  • K060676 — NES REPROCESSED ENDOSCOPIC TROCAR (September 7, 2007)

Other clearances for product code NUJ

  • K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (April 29, 2024)
  • K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (March 28, 2023)
  • K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (May 13, 2022)
  • K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer (April 7, 2022)
  • K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (October 22, 2019)
  • K182588 — Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (October 31, 2018)
  • K180499 — Reprocessed LigaSure Maryland Jaw Sealer/Divider (April 23, 2018)
  • K180451 — Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (April 20, 2018)
  • K173214 — NES Reprocessed RF Stylet (RFS) (March 27, 2018)
  • K173740 — Reprocessed DePuy Mitek Ablation Wand (March 19, 2018)