Company ยท US
Surgical Instrument Service and Savings, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2025. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (2 in 12 months)
22recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 7 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 4 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 3 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 2 |
| EMF | Knife, Surgical | 1 |
| GAE | Snare, Surgical | 1 |
| GAG | Stapler, Surgical | 1 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 1 |
| GDF | Guide, Needle, Surgical | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 |
| HRH | Trephine, Manual, Ophthalmic | 1 |
| HRX | Arthroscope | 1 |
| HTR | Rasp | 1 |
| HTW | Bit, Drill | 1 |
| HWQ | Passer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2025 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer Surgical Instrument Service and Savings, Inc. | PNE |
| Nov 26, 2025 | K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter Surgical Instrument Service and Savings, Inc. | NLH |
| Jul 11, 2025 | K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter Surgical Instrument Service and Savings, Inc. | NLH |
| Jun 5, 2025 | K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) Surgical Instrument Service and Savings, Inc. | OWQ |
| Mar 10, 2025 | K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReN Surgical Instrument Service and Savings, Inc. | OWQ |
| Nov 29, 2024 | K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter Surgical Instrument Service and Savings, Inc. | NLH |
| Sep 14, 2024 | K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (40 Surgical Instrument Service and Savings, Inc. | NLH |
| Sep 10, 2024 | K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNew Surgical Instrument Service and Savings, Inc. | OWQ |
| Jun 7, 2024 | K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) Surgical Instrument Service and Savings, Inc. | NLH |
| Apr 29, 2024 | K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) Surgical Instrument Service and Savings, Inc. | NUJ |
| May 31, 2023 | K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter Surgical Instrument Service and Savings, Inc. | NLH |
| Jul 3, 2019 | K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors Surgical Instrument Service and Savings, Inc. | NLF |
| Apr 15, 2019 | K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer Surgical Instrument Service and Savings, Inc. | NLM |
| Jul 27, 2018 | K180580 | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices Surgical Instrument Service and Savings, Inc. | KTT |
| Jul 12, 2018 | K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector Surgical Instrument Service and Savings, Inc. | NLQ |
| Nov 9, 2017 | K171911 | Medline ReNewal Reprocessed Synthes External Fixation Systems Surgical Instrument Service and Savings, Inc. | KTT |
| Oct 18, 2017 | K172608 | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes Surgical Instrument Service and Savings, Inc. | NUJ |
| Aug 3, 2017 | K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds Surgical Instrument Service and Savings, Inc. | JCX |
| Jun 23, 2017 | K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Surgical Instrument Service and Savings, Inc. | NUJ |
| May 18, 2017 | K161272 | Supreme and Response Electrophysiology Catheters Surgical Instrument Service and Savings, Inc. | NLH |
| Dec 28, 2016 | K163028 | Medline ReNewal Reprocessed Stryker External Fixation Devices Surgical Instrument Service and Savings, Inc. | JEC |
| Jul 20, 2016 | K160333 | Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider Surgical Instrument Service and Savings, Inc. | NUJ |
| May 6, 2016 | K160740 | Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology Surgical Instrument Service and Savings, Inc. | NLM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762
Unclassified Terminated |
NLQ | K012669 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5. Terminated |
NLM | K012644 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215
- TurboSonics Mini-Flared ABS Tip, 20 Degree Tip Angle, 45 Kelman, (Purplish Pink/Silver Terminated |
NKX | K030179 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609
- CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. Terminated |
NBH | K012667 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504
- Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511
- ENDO Terminated |
LXH | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429
- Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429
Manual surgical instrument for ge Terminated |
KAM | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Calf Garment Standard Ref. L501-M Lot 122549, 122985
- Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546
- Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570
- SCD Express Compres Terminated |
JOW | K012658 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447.
Orthopedic manual surgical instrument Terminated |
HWX | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511
- IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631
Passer Terminated |
HWQ | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511
- Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322
- Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 14 Terminated |
HTW | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347
Manual surgical instrument for general use Terminated |
HTR | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270
- AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665
- AcromioBlaster Burr (Sage Green) 4.0mm Ref Terminated |
HRX | K012667 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336
Opthalmic Terminated |
HRH | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665
- Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannula Terminated |
GFF | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447
- Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lo Terminated |
GFA | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875
Manual surgical instrument for general use. Terminated |
GEN | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502
-Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288
-CAPSure 30 A Terminated |
GEI | K012669 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N
Lot 123263
-SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279
-Suture Passing Wire. Ref. AR-1255 Terminated |
GDF | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266
General and Plastic Surgery Terminated |
GAS | K041115 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300.
-Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300.
- Ethicon P Terminated |
GAG | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592.
- Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25 Terminated |
GAE | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279
-Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669
-Linvatec CTS Relief Kit. REF Terminated |
EMF | None listed |