Sparta Surgical Corp.: FDA clearances and approvals
Sparta Surgical Corp. has 7 FDA 510(k) clearances (first 1989, latest 1997), across 7 product codes in 4 review panels. Median 510(k) review time: 78 days.
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 |
|---|---|---|---|
| FMF | Syringe, Piston | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GEC | Brush, Scrub, Operating-Room | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| KDC | Instrument, Surgical, Disposable | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
Review panels
- General and Plastic Surgery (4)
- General Hospital (1)
- Neurology (1)
- Ophthalmic (1)
Most recent Sparta Surgical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965187 | SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD | GZJ | 1997-08-01 | 220 |
| K945313 | SPARTA HYDROGEL WOUND DRESSING | MGQ | 1995-01-12 | 72 |
| K922729 | SPARTA WET DRESSING, SODIUM CHLORIDE | FRO | 1992-11-23 | 171 |
| K905384 | DAVID SIMMONDS ANESTHESIA EXTENSION TUBES | FMF | 1991-03-22 | 113 |
| K905240 | VESSELOOPS | KDC | 1991-02-06 | 78 |
| K896085 | SURGI-BRUSH | GEC | 1989-11-08 | 20 |
| K896084 | MICROSPEARS | HOZ | 1989-11-02 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Sparta Surgical Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sparta Surgical Corp. have?
Sparta Surgical Corp. has 7 FDA 510(k) clearances (first 1989, latest 1997), across 7 product codes in 4 review panels.
How long does FDA take to clear Sparta Surgical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Sparta Surgical Corp.'s cleared 510(k)s is 78 days.
What devices does Sparta Surgical Corp. make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 1); FRO (Dressing, Wound, Drug, 1); GEC (Brush, Scrub, Operating-Room, 1).
Has Sparta Surgical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sparta Surgical Corp. Related entities may recall under other names.
Next steps
- See all 7 Sparta Surgical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Sparta Surgical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.