Data / Medical devices / United States / Northeast Scientific, Inc.
Northeast Scientific, Inc.: FDA-registered device maker in Waterbury, CT, United States, 7 510(k) clearances
Northeast Scientific, Inc. is registered with the FDA (registration 3005467144) in Waterbury, CT, United States. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 12, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005467144
- Address
- 2142 Thomaston Ave, Waterbury, CT, United States, 06704
- Owner or operator
- NORTHEAST SCIENTIFIC, INC. (9079660)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 13, 2011
- Registered through
- 2026
- Brand names listed
- 700004 Vein Ablation Pack, 700005 Vein Ablation Pack, EsoSure, NES IVUS Smart Reprocessed IVUS Catheter, NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter, NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter, NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter, NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reprocessed Atherectomy Catheter | QTF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 12, 2025 | K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | OWQ | Substantially Equivalent | Northeast Scientific, Inc. | accessdata.fda.gov |
| February 3, 2023 | K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | OWQ | Substantially Equivalent | Northeast Scientific, Inc. | accessdata.fda.gov |
| July 1, 2022 | K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | QTF | Substantially Equivalent | Northeast Scientific, Inc. | accessdata.fda.gov |
| June 22, 2020 | K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | OBJ | Substantially Equivalent | Northeast Scientific, Inc. | accessdata.fda.gov |
| January 18, 2019 | K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter | OWQ | Substantially Equivalent | Innovative Health, LLC | accessdata.fda.gov |
| March 27, 2018 | K173214 | NES Reprocessed RF Stylet (RFS) | NUJ | Substantially Equivalent | Northeast Scientific, Inc. (Nes) | accessdata.fda.gov |
| July 21, 2010 | K090661 | NES REPROCESSED VARICOSE VEIN RF CATHETER | NUJ | Substantially Equivalent | Northeast Scientific, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 29, 2025 | 97524 | Class II | Ongoing | NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infra | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | accessdata.fda.gov |
| April 26, 2021 | 88345 | Class II | Terminated | NES Reprocessed Visions PV.035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-8 | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- All makers of Reprocessed Intravascular Ultrasound Catheter
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Retractor
- All makers of Tray, Surgical
Updated October 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.