Surgical Instrument Service and Savings, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Surgical Instrument Service and Savings, Inc.” (first 2016, latest 2025), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 141 days. Since 2017 the median was 142 days, against 122 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 3 | 58 |
| 2017 | 5 | 136 |
| 2018 | 2 | 187 |
| 2019 | 2 | 134 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 414 |
| 2024 | 5 | 141 |
| 2025 | 5 | 120 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Surgical Instrument Service and Savings, Inc. took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 7 | 7 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 4 | 4 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 2 | 2 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
| NLF | Oximeter, Reprocessed | 1 | 1 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 1 | 1 |
| PNE | Reprocessed Catheter Introducer | 1 | 1 |
Review panels
- Cardiovascular (11)
- General and Plastic Surgery (6)
- Orthopedic (3)
- Gastroenterology and Urology (2)
- Anesthesiology (1)
Most recent Surgical Instrument Service and Savings, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | PNE | 2025-12-19 | 318 |
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | NLH | 2025-11-26 | 118 |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | NLH | 2025-07-11 | 120 |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | OWQ | 2025-06-05 | 100 |
| 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) | OWQ | 2025-03-10 | 161 |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | NLH | 2024-11-29 | 123 |
| 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 | NLH | 2024-09-14 | 141 |
| 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) | OWQ | 2024-09-10 | 263 |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | NLH | 2024-06-07 | 59 |
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | NUJ | 2024-04-29 | 255 |
13 earlier clearances. See the full list in Caduvo.
Recalls
22 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-05-03.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Surgical Laser Technologies, Inc. (51 510(k)s)
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Navigation Technologies, Inc. (27 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Technology Laboratories, Inc. (12 510(k)s)
- Surgical Appliance Industries, Inc. (9 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Theater, Inc. (8 510(k)s)
- Surgical Information Sciences, Inc. (7 510(k)s)
- Surgical Innovations Plc (7 510(k)s)
- Surgical Specialties Corp. Dba Angiotech (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Instrument Service and Savings, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Surgical Instrument Service and Savings, Inc.” (first 2016, latest 2025), across 10 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Surgical Instrument Service and Savings, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Instrument Service and Savings, Inc. is 141 days. Since 2017: 142 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Surgical Instrument Service and Savings, Inc.?
The most frequent FDA product codes under this applicant name are NLH (Catheter, Recording, Electrode, Reprocessed, 7); NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, 4); OWQ (Reprocessed Intravascular Ultrasound Catheter, 3).
Next steps
- See all 23 Surgical Instrument Service and Savings, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NLH, Surgical Instrument Service and Savings, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.