# Northeast Scientific, Inc.

- Location (FDA's records): Waterbury, CT
- FDA decisions: 6 (2007–2025): 6 510(k) clearances
- Product codes: OWQ (2), NLM (1), OBJ (1), NUJ (1), QTF (1)
- 510(k) review time since 2016: median 127 days, against 100 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 11 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 4 (https://510kreport.com/company/ethicon-endo-surgery)
- Volcano Corporation: 2 (https://510kreport.com/company/volcano)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)
- Vnus Medical Technologies, Inc.: 1 (https://510kreport.com/company/vnus-medical-technologies)
- Spectranetics Corp.: 1 (https://510kreport.com/company/spectranetics)
- Innovative Health, LLC: 1 (https://510kreport.com/company/innovative-health)

## Its most-cited devices
- K200195: NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (2020), cited by 1

## Recent decisions
- K250592: NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (May 12, 2025)
- K223026: NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (Feb 3, 2023)
- K220171: NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (Jul 1, 2022)
- K200195: NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (Jun 22, 2020)
- K090661: Nes Reprocessed Varicose Vein RF Catheter (Jul 21, 2010)
- K060676: Nes Reprocessed Endoscopic Trocar (Sep 7, 2007)

Source page: https://510kreport.com/company/northeast-scientific