Springfield Surgical Instruments: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Springfield Surgical Instruments” (first 1993, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 40 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 | 0 | — |
| 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Springfield Surgical Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953410 | BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR | GCJ | 1995-09-29 | 71 |
| K952785 | BRIMFIELD PRECISION DETACHABLE SCISSOR | GCJ | 1995-07-26 | 37 |
| K946263 | BRIMFIELD PRECISION GRASPER/DISSECTOR | GCJ | 1995-01-26 | 34 |
| K942499 | INSULATED SURGICAL ELECTRODE | GEI | 1994-07-01 | 38 |
| K941276 | BRIMFIELD PRECISION SECOND GENERATION GRASPER/DISSECTOR | GCJ | 1994-04-29 | 43 |
| K941316 | BRIMFIELD PRECISION FAN RETRACTOR | GCJ | 1994-04-22 | 35 |
| K933388 | BRIMFIELD PRECISION SCISSOR | GCJ | 1993-10-21 | 101 |
| K933387 | BRIMFIELD PRECISION GRASPER/DISSECTOR | GCJ | 1993-10-15 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Springfield Surgical Instruments.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Springfield Surgical Instruments?
FDA lists 8 510(k) clearances under the applicant name “Springfield Surgical Instruments” (first 1993, latest 1995), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Springfield Surgical Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Springfield Surgical Instruments is 40 days.
Which FDA product codes appear under Springfield Surgical Instruments?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 7); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 8 Springfield Surgical Instruments clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Springfield Surgical Instruments'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.