Surgical Instruments Service and Savings, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Surgical Instruments Service and Savings, Inc.” (first 2002, latest 2014), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 284 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 375 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| NKX | Needle, Phacoemulsification, Reprocessed | 1 | 1 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 1 | 1 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 1 | 1 |
| NLU | Forceps, Biopsy, Electric, Reprocessed | 1 | 1 |
Review panels
- General and Plastic Surgery (3)
- Gastroenterology and Urology (2)
- Cardiovascular (1)
- Ophthalmic (1)
- Orthopedic (1)
Most recent Surgical Instruments Service and Savings, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K124033 | MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS | NLQ | 2014-01-07 | 375 |
| K031869 | SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES | GEI | 2003-12-24 | 190 |
| K030179 | MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES | NKX | 2003-01-24 | 7 |
| K024011 | SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES | NLU | 2002-12-19 | 15 |
| K012644 | REPROCESSED TROCARS AND CANNULAS | NLM | 2002-07-29 | 350 |
| K012669 | REPROCESSED ELECTROSURGICAL ELECTRODES | GEI | 2002-06-27 | 318 |
| K012667 | REPROCESSED ARTHROSCOPIC SHAPERS | HRX | 2002-06-03 | 294 |
| K012658 | REPROCESSED COMPRESSION LIMB SLEEVES | JOW | 2002-05-14 | 274 |
Recalls
openFDA lists no recalls under a recalling firm named Surgical Instruments Service and Savings, Inc..
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 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 Instruments Service and Savings, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Surgical Instruments Service and Savings, Inc.” (first 2002, latest 2014), across 7 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 Instruments Service and Savings, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Instruments Service and Savings, Inc. is 284 days.
Which FDA product codes appear under Surgical Instruments Service and Savings, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HRX (Arthroscope, 1); JOW (Sleeve, Limb, Compressible, 1).
Next steps
- See all 8 Surgical Instruments Service and Savings, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Surgical Instruments 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.