# Surgical Information Sciences, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 7 (2017–2024): 7 510(k) clearances
- Product codes: LLZ (4), QIH (3)
- 510(k) review time since 2016: median 56 days, against 116 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 8 (6 its own); citations of its devices by later devices: 8 (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
- Medtronic Surgical Navigation Technologies: 1 (https://510kreport.com/company/medtronic-surgical-navigation-technologies)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)

## Firms that cite its devices most
- Rebrain, Sas: 1 (https://510kreport.com/company/rebrain)
- Omniscient Neurotechnology Pty, Ltd.: 1 (https://510kreport.com/company/omniscient-neurotechnology)

## Its most-cited devices
- K162830: SIS Software (2017), cited by 2
- K192304: SIS Software Version 3.6.0 (2019), cited by 1
- K230977: SIS System (2023), cited by 1
- K223032: SIS System (Version 5.6.0) (2022), cited by 1
- K210071: SIS System (Version 5.1.0) (2021), cited by 1
- K183019: SIS Software version 3.3.0 (2019), cited by 1

## Recent decisions
- K241083: SIS System (Jun 14, 2024)
- K230977: SIS System (May 2, 2023)
- K223032: SIS System (Version 5.6.0) (Nov 21, 2022)
- K210071: SIS System (Version 5.1.0) (Mar 31, 2021)
- K192304: SIS Software Version 3.6.0 (Sep 13, 2019)
- K183019: SIS Software version 3.3.0 (Mar 19, 2019)
- K162830: SIS Software (Feb 14, 2017)

Source page: https://510kreport.com/company/surgical-information-sciences