# Electrocore, LLC

- Location (FDA's records): Basking Ridge, NJ
- FDA decisions: 8 (2017–2021): 7 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Electrocore, LLC (4); Electrocore, Inc. (4)
- Product codes: PKR (8)
- 510(k) review time since 2016: median 78 days, against 78 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (6 its own); citations of its devices by later devices: 7 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Eletrocore, LLC: 1 (https://510kreport.com/company/eletrocore)

## Firms that cite its devices most
- Eletrocore, LLC: 1 (https://510kreport.com/company/eletrocore)

## Its most-cited devices
- K171306: gammaCore-S (2017), cited by 2
- K180538: gammaCore Sapphire (2018), cited by 1
- DEN150048: gammaCore Non-invasive Vagus Nerve Stimulator (2017), cited by 1
- K182369: gammaCore Sapphire (2018), cited by 1
- K191830: gammaCore Sapphire (2020), cited by 1
- K203546: gammaCore Sapphire (2021), cited by 1

## Recent decisions
- K211856: gammaCore Sapphire (Sep 10, 2021)
- K203546: gammaCore Sapphire (Feb 12, 2021)
- K191830: gammaCore Sapphire (Mar 26, 2020)
- K182369: gammaCore Sapphire (Nov 27, 2018)
- K180538: gammaCore Sapphire (Mar 30, 2018)
- K173442: gammaCore-S (Jan 23, 2018)
- K171306: gammaCore-S (May 30, 2017)
- DEN150048: gammaCore Non-invasive Vagus Nerve Stimulator (Apr 14, 2017)

Source page: https://510kreport.com/company/electrocore