# Surgical Instrument Service and Savings, Inc.

- Location (FDA's records): Redmond, OR
- FDA decisions: 23 (2016–2025): 23 510(k) clearances
- Product codes: NLH (7), NUJ (4), OWQ (3), KTT (2), NLM (2), JCX (1), NLQ (1), NLF (1), JEC (1), PNE (1)
- 510(k) review time since 2016: median 136 days, against 149 for FDA's reviews in the same codes and years (6 of 11 faster)
- Predicates its devices cite: 26 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 18 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- St Jude Medical: 3 (https://510kreport.com/company/st-jude-medical)
- Covidien: 3 (https://510kreport.com/company/covidien)
- Biosense Webster, Inc.: 2 (https://510kreport.com/company/biosense-webster)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Irvine Biomedical, Inc.: 2 (https://510kreport.com/company/irvine-biomedical)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Recent decisions
- K250314: Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (Dec 19, 2025)
- K252405: Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter (Nov 26, 2025)
- K250772: Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter (Jul 11, 2025)
- K250545: Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (Jun 5, 2025)
- K243101: Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (Mar 10, 2025)
- K242225: Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (Nov 29, 2024)
- K241156: Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207,  401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 (Sep 14, 2024)
- K234064: Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) (Sep 10, 2024)

Source page: https://510kreport.com/company/surgical-instrument-service-and-savings