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Surgical Instrument Service and Savings, Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories10
Latest FDA decision2025-12-19
TypeNumberDevice NameCodeDateActions
510(k) K250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerPNE2025-12-19 View
510(k) K252405 Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterNLH2025-11-26 View
510(k) K250772 Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterNLH2025-07-11 View
510(k) K250545 Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)OWQ2025-06-05 View
510(k) 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)OWQ2025-03-10 View
510(k) K242225 Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNLH2024-11-29 View
510(k) 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, 401NLH2024-09-14 View
510(k) 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)OWQ2024-09-10 View
510(k) K240972 Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)NLH2024-06-07 View
510(k) K232511 Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)NUJ2024-04-29 View
510(k) K221067 Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterNLH2023-05-31 View
510(k) K191018 Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsNLF2019-07-03 View
510(k) K182828 Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserNLM2019-04-15 View
510(k) K180580 Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation DevicesKTT2018-07-27 View
510(k) K173627 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ2018-07-12 View
510(k) K171911 Medline ReNewal Reprocessed Synthes External Fixation SystemsKTT2017-11-09 View
510(k) K172608 Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesNUJ2017-10-18 View
510(k) K161358 Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsJCX2017-08-03 View
510(k) K171324 Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsNUJ2017-06-23 View
510(k) K161272 Supreme and Response Electrophysiology CathetersNLH2017-05-18 View

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