Surgical Instrument Service and Savings Inc.(Dba Medline Ren: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Surgical Instrument Service and Savings Inc.(Dba Medline Ren” (first 2016, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 161 days. Since 2017 the median was 146 days, against 140 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 | 2 | 173 |
| 2017 | 1 | 94 |
| 2018 | 1 | 41 |
| 2019 | 0 | — |
| 2020 | 1 | 240 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 197 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Surgical Instrument Service and Savings Inc.(Dba Medline Ren took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NLH | Catheter, Recording, Electrode, Reprocessed | 2 | 2 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 2 | 2 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 2 | 2 |
Review panels
Most recent Surgical Instrument Service and Savings Inc.(Dba Medline Ren 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) | NLH | 2024-11-15 | 197 |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | NLQ | 2020-08-19 | 240 |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider | NUJ | 2018-10-31 | 41 |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | NLQ | 2017-07-03 | 94 |
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider | NUJ | 2016-05-02 | 125 |
| K151617 | Livewire Electrophysiology Catheter | NLH | 2016-01-22 | 221 |
Recalls
openFDA lists no recalls under a recalling firm named Surgical Instrument Service and Savings Inc.(Dba Medline Ren.
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 Instrument Service and Savings, Inc. (23 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Instrument Service and Savings Inc.(Dba Medline Ren?
FDA lists 6 510(k) clearances under the applicant name “Surgical Instrument Service and Savings Inc.(Dba Medline Ren” (first 2016, latest 2024), across 3 product codes in 2 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.(Dba Medline Ren?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Instrument Service and Savings Inc.(Dba Medline Ren is 161 days. Since 2017: 146 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Surgical Instrument Service and Savings Inc.(Dba Medline Ren?
The most frequent FDA product codes under this applicant name are NLH (Catheter, Recording, Electrode, Reprocessed, 2); NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments, 2); NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, 2).
Next steps
- See all 6 Surgical Instrument Service and Savings Inc.(Dba Medline Ren clearances with predicates and recalls
- Run predicate analysis for product code NLH, Surgical Instrument Service and Savings Inc.(Dba Medline Ren'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.