Northeast Scientific Inc.
Waterbury, CT, US
NORTHEAST SCIENTIFIC, INC. appears in FDA device records in Waterbury, CT. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Northeast Scientific Inc. between 2007 and 2025. The busiest year on record is 2007, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2010 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | OWQ | Substantially Equivalent | |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | OWQ | Substantially Equivalent | |
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | QTF | Substantially Equivalent | |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | OBJ | Substantially Equivalent | |
| K090661 | NES REPROCESSED VARICOSE VEIN RF CATHETER | NUJ | Substantially Equivalent | |
| K060676 | NES REPROCESSED ENDOSCOPIC TROCAR | NLM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005467144 | 3005467144 | NORTHEAST SCIENTIFIC, INC. | 2142 Thomaston Ave, Waterbury, CT 06704 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OBJCatheter, Ultrasound, Intravascular
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- NLMLaparoscope, General & Plastic Surgery, Reprocessed
- QTFReprocessed Atherectomy Catheter
- OWQReprocessed Intravascular Ultrasound Catheter
- GADRetractor
- LRPTray, Surgical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0025-2026 | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Open, Classified | |
| Z-0024-2026 | NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Open, Classified | |
| Z-0023-2026 | NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Open, Classified | |
| Z-0022-2026 | NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Open, Classified | |
| Z-0021-2026 | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Open, Classified | |
| Z-0020-2026 | NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Open, Classified | |
| Z-0019-2026 | NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Open, Classified | |
| Z-0018-2026 | 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 infrainguinal stenoses and occlusions. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Open, Classified | |
| Z-2334-2021 | 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-88901 | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain