# Elliquence, LLC

- Location (FDA's records): Baldwin, NY
- FDA decisions: 8 (2010–2025): 8 510(k) clearances
- Product codes: GEI (6), HRX (1), MAX (1)
- 510(k) review time since 2016: median 80 days, against 85 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 16 (2 its own); citations of its devices by later devices: 9 (2 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
- Peak Surgical, Inc.: 2 (https://510kreport.com/company/peak-surgical)
- Ellman International, Inc.: 2 (https://510kreport.com/company/ellman-international)
- Valleylab, Inc.: 2 (https://510kreport.com/company/valleylab)
- Rz Medizintechnik GmbH: 1 (https://510kreport.com/company/rz-medizintechnik)
- Ellman Int'L, Inc.: 1 (https://510kreport.com/company/ellman-int-l)
- Bovie Medical Corporation: 1 (https://510kreport.com/company/bovie-medical)
- Astura Medical: 1 (https://510kreport.com/company/astura-medical)
- Orthofix US, LLC: 1 (https://510kreport.com/company/orthofix-us)

## Firms that cite its devices most
- Soniquence, LLC: 4 (https://510kreport.com/company/soniquence)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Jaco, LLC Dba Macan Manufacturing and Bna Burz North America: 1 (https://510kreport.com/company/jaco-dba-macan-manufacturing-and-bna-burz-north-america)
- Sutter Medizintechnik GmbH: 1 (https://510kreport.com/company/sutter-medizintechnik)

## Its most-cited devices
- K100390: Surgimax/ Surgimax Plus (2010), cited by 2
- K170107: Surgi Max Ultra (2017), cited by 2
- K142410: Elliquence Electrodes (2015), cited by 2
- K180766: Endiscope, Endiscope Cervical (2018), cited by 1
- K160041: Cobbra RF Tissue Dissector (2016), cited by 1
- K130110: Meddusa Bipolar System (2013), cited by 1

## Recent decisions
- K243739: AxCess® Expandable Interbody System (Jan 24, 2025)
- K180766: Endiscope, Endiscope Cervical (Jun 11, 2018)
- K170107: Surgi Max Ultra (May 3, 2017)
- K162490: Disc-FX System (Jan 6, 2017)
- K160041: Cobbra RF Tissue Dissector (Mar 7, 2016)
- K142410: Elliquence Electrodes (Oct 30, 2015)
- K130110: Meddusa Bipolar System (Oct 8, 2013)
- K100390: Surgimax/ Surgimax Plus (Aug 25, 2010)

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