# Spirus Medical, Inc.

- Location (FDA's records): Ayer, MA
- FDA decisions: 5 (2005–2008): 5 510(k) clearances
- Product codes: FED (3), KMJ (1), FDA (1)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 7 (3 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
- Fujinon, Inc.: 2 (https://510kreport.com/company/fujinon)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- United States Endoscopy Group, Inc.: 2 (https://510kreport.com/company/united-states-endoscopy-group)
- Johnson & Johnson Professionals, Inc.: 1 (https://510kreport.com/company/johnson-johnson-professionals)
- Davryan Laboratories, Inc.: 1 (https://510kreport.com/company/davryan-laboratories)

## Firms that cite its devices most
- United States Endoscopy Group, Inc.: 2 (https://510kreport.com/company/united-states-endoscopy-group)
- Syntheon, LLC: 1 (https://510kreport.com/company/syntheon)
- Softscope Medical Technologies, Inc.: 1 (https://510kreport.com/company/softscope-medical-technologies)

## Its most-cited devices
- K052084: Endo-Ease Endoscopic Overtube (2005), cited by 4
- K080050: Spirus Medical Endo-Ease Endoscopic Overtube (2008), cited by 1
- K062805: Modification to Endo-Ease (2006), cited by 1
- K060235: Endo-Ease Endoscopic Overtube (2006), cited by 1

## Recent decisions
- K080050: Spirus Medical Endo-Ease Endoscopic Overtube (May 6, 2008)
- K080042: Spirus Medical Surgical Instrument (Apr 3, 2008)
- K062805: Modification to Endo-Ease (Oct 13, 2006)
- K060235: Endo-Ease Endoscopic Overtube (Aug 4, 2006)
- K052084: Endo-Ease Endoscopic Overtube (Sep 14, 2005)

Source page: https://510kreport.com/company/spirus-medical